Method and device for securing body tissue

ABSTRACT

A suture and a suture retainer are positioned relative to body tissue. Ultrasonic vibratory energy is utilized to heat the suture retainer and effect a bonding of portions of the suture retainer to each other and/or to the suture. Portions of the body tissue may be pressed into linear apposition with each other and held in place by cooperation between the suture and the suture retainer. The suture retainer may include one or more portions between which the suture extends. The suture retainer may include sections which have surface areas which are bonded together. If desired, the suture may be wrapped around one of the sections of the suture retainer. The suture retainer may be formed with a recess in which the suture is received. If desired, the suture retainer may be omitted and the sections of the suture bonded to each other.

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 10/779,978, filed Feb. 17, 2004, which is acontinuation-in-part of U.S. patent application Ser. No. 10/228,855,filed Aug. 27, 2002, and is a continuation-in-part of U.S. patentapplication Ser. No. 10/458,117, filed Jun. 10, 2003, which is adivisional of U.S. patent application Ser. No. 10/076,919, filed Feb.15, 2002, now U.S. Pat. No. 6,585,750, which is a divisional of U.S.patent application Ser. No. 09/524,397, filed Mar. 13, 2000, now U.S.Pat. No. 6,368,343. The contents of each of the above applications andpatents are herein incorporated by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to methods and devices for securingbody tissue by using ultrasonic vibratory energy and other forms ofenergy.

BACKGROUND OF THE INVENTION

[0003] Difficulty has been encountered in securing sutures againstmovement relative to body tissue. A knot may be tied in a suture toprevent loosening of the suture. However, the knot weakens a portion ofthe suture and reduces the overall force transmitting capability of thesuture. It has been suggested that a suture could be secured using asuture retainer in the manner disclosed in U.S. Pat. Nos. 5,735,875 and6,010,525.

[0004] When a suture retainer is used to maintain a suture in a desiredposition relative to body tissue, the material of the suture retainermay be pressed against the suture. During pressing of the material ofthe retainer against the suture, the suture may be heated to promote aflowing of the material of the suture retainer and bonding to thematerial of the suture retainer to the surface of the suture by heatingmaterial of the suture retainer into its transition temperature range.

[0005] When the material of the suture retainer is heated into itstransition temperature range, the material changes from a solidcondition in which it has a fixed form to a soft or viscous condition.When the material of a suture retainer has been heated into thetransition temperature range, the material can be molded around an outerside surface of a suture and bonded to the suture without significantdeformation of the suture. The transition temperature ranges for variouspolymers which are suitable for forming suture retainers are disclosedin the aforementioned U.S. Pat. No. 5,735,875.

SUMMARY OF THE INVENTION

[0006] The present invention provides a new and improved method for usein securing body tissue. If desired, a suture retainer may be used togrip the suture. When a suture retainer is used, ultrasonic vibratoryenergy is transmitted to the material of the suture retainer to effect aheating of at least some of the material of the suture retainer.Portions of the suture retainer are then bonded to each other and/or tothe suture.

[0007] It may be desired to retain layers of body tissue in linearapposition with each other. When this is to be done, a suture is used tohold the layers of body tissue in linear apposition after they have beenapproximated to each other. The suture may be secured relative to thebody tissue by a suture retainer or crimp. Alternatively, sections ofthe suture may be secured together. To secure the suture relative to thebody tissue, ultrasonic vibratory energy is applied to either the sutureor the suture retainer. The ultrasonic energy may be applied while thesuture is being tensioned with a predetermined force and while apredetermined force is being transmitted to the body tissue.

[0008] The suture retainer or crimp may have any one of many differentconstructions. One specific suture retainer constructed in accordancewith one of the features of the present invention includes one or morepassages through which one or more sections of the suture are inserted.In another embodiment of the invention, the suture retainer has sectionswhich are formed separately from each other. The sections of the sutureretainer are connected with the suture and/or each other by transmittingultrasonic vibratory energy to at least one of the sections of thesuture.

[0009] If desired, the suture may be wrapped around a portion of thesuture retainer. The suture retainer may be provided with one or morerecesses into which one or more sections of the suture are moved. Thetransmission of ultrasonic vibratory energy to the suture retainer isutilized to effect a bonding of portions of the suture retainer witheach other and/or with the suture.

[0010] The suture retainer may be omitted and sections of the suturebonded to each other. When this is to be done, ultrasonic vibratoryenergy is transmitted to the sections of the suture. Force is appliedagainst opposite sides of the sections of the suture to increase theextent of the sections of the suture in a direction transverse to thesections of the suture. As the transverse extent of the suture isincreased, areas on outer side surfaces of the sections of the sutureare increased.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing and other features of the invention will becomemore apparent upon a consideration of the following description taken inconnection with the accompanying drawings wherein:

[0012]FIG. 1 is a schematic illustration depicting the manner in whichlayers of body tissue are moved into linear apposition with each otherand secured with a suture and suture retainer;

[0013]FIG. 2 is a schematic fragmentary sectional view illustrating themanner in which the suture and suture retainer of FIG. 1 are positionedrelative to each other;

[0014]FIG. 3 is a fragmentary schematic illustration depicting themanner in which ultrasonic vibratory energy is applied to the sutureretainer of FIG. 2;

[0015]FIG. 4 is a schematic fragmentary sectional view of anotherembodiment of the invention and illustrating the approximation of layersof tissue by tensioning a suture with a predetermined force and pressinga suture retainer against the body tissue with a predetermined force;

[0016]FIG. 5 is a schematic fragmentary sectional view of anotherembodiment of the invention and illustrating the manner in a vibrationapplicator member engages a suture retainer which is being pressedagainst body tissue with a predetermined force while an associatedsuture is tensioned with a predetermined force;

[0017]FIG. 6 is a schematic fragmentary pictorial illustration ofanother embodiment of the invention and depicting the construction ofsections of a suture retainer and the relationship of the sections ofthe suture retainer to apparatus for applying ultrasonic vibratoryenergy to the suture retainer;

[0018]FIG. 7 is a schematic pictorial illustration of an embodiment ofthe invention in which a suture retainer has a pair of passages forreceiving sections of a suture;

[0019]FIG. 8 is a schematic illustration depicting the manner in whichultrasonic vibratory energy is applied to the suture retainer of FIG. 7;

[0020]FIG. 9 is an exploded fragmentary schematic illustration ofanother embodiment of the invention and depicting the manner in which asuture is wrapped around a section of a suture retainer and therelationship of apparatus for applying ultrasonic vibratory energy tosections of the suture retainer;

[0021]FIG. 10 is a schematic pictorial illustration of anotherembodiment of the invention and depicting the manner in which sectionsof a suture extend through passages in a section of a suture retainer;

[0022]FIG. 11 is a schematic fragmentary sectional view depicting therelationship of the section of the suture retainer illustrated in FIG.10 to other sections of the suture retainer and to an apparatus forapplying ultrasonic vibratory energy to the suture retainer;

[0023]FIG. 12 is a schematic illustration of another embodiment of theinvention and depicting the relationship between sections of a sutureand sections of a suture retainer;

[0024]FIG. 13 is a top plan view, taken generally along the line 13-13of FIG. 12, illustrating the relationship of the sections of the sutureretainer and suture to an apparatus for applying ultrasonic vibratoryenergy to the suture retainer;

[0025]FIG. 14 is a schematic illustration of another embodiment of theinvention and depicting the manner in which sections of a suture arewrapped around a section of a suture retainer;

[0026]FIG. 15 is a schematic sectional view, taken generally along theline 15-15 of FIG. 14, illustrating the relationship between sections ofthe suture retainer and an apparatus for applying ultrasonic vibratoryenergy to the suture retainer;

[0027]FIG. 16 is a schematic plan view of another embodiment of theinvention, illustrating the relationship of sections of a suture torecesses formed in a suture retainer which is disposed between portionsof an apparatus for applying ultrasonic vibratory energy to the sutureretainer;

[0028]FIG. 17 is an enlarged fragmentary schematic illustrationdepicting the manner in which a section of the suture is moved into oneof the recesses in the suture retainer of FIG. 16;

[0029]FIG. 18 is a schematic pictorial illustration depicting the mannerin which another embodiment of the suture retainer is positionedrelative to the suture;

[0030]FIG. 19 is a plan view, taken generally along the line 19-19 ofFIG. 18, illustrating the relationship between the suture retainer andthe suture;

[0031]FIG. 20 is a plan view, generally similar to FIG. 19, illustratingthe relationship of an apparatus for applying ultrasonic vibratoryenergy to the suture retainer and the suture retainer and suture of FIG.19;

[0032]FIG. 21 is a schematic pictorial illustration of an embodiment ofthe suture retainer having a recess which receives a portion of asuture;

[0033]FIG. 22 is a plan view of another embodiment of the invention andillustrating the manner in which a suture is positioned in a recess inthe suture retainer and the relationship of apparatus for applyingultrasonic vibratory energy to the suture retainer;

[0034]FIG. 23 is a schematic illustration of another embodiment of theinvention and depicting the manner in which a suture and a sutureretainer are utilized to hold layers of body tissue in apposition witheach other;

[0035]FIG. 24 is a schematic illustration of one apparatus for applyingultrasonic vibratory energy to a suture retainer;

[0036]FIG. 25 is a schematic illustration of a second apparatus forapplying ultrasonic vibratory energy to a suture retainer;

[0037]FIG. 25A is a schematic illustration of an ultrasonic vibratorytransmission device for FIGS. 24 and 25;

[0038]FIG. 26 is a schematic illustration, similar to FIG. 1, depictingthe manner in which layers of body tissue are moved into linearapposition with each other and secured with a suture;

[0039]FIG. 27 is a schematic fragmentary sectional view illustrating themanner in which sections of the suture of FIG. 26 are positionedrelative to each other and to apparatus which applies ultrasonicvibratory energy to the sections of the suture;

[0040]FIG. 28 is a schematic illustration depicting the manner in whichsections of the suture of FIG. 27 are extended;

[0041]FIG. 29 is a schematic illustration of another embodiment of thesuture retainer of FIGS. 1-4;

[0042]FIGS. 30A-30B are schematic illustrations of another embodiment ofthe invention and depicting the relationship between sections of asuture and sections of a suture retainer;

[0043]FIG. 31 is a schematic illustration of another embodiment of theinvention and depicting the relationship between sections of a sutureand sections of a suture retainer;

[0044]FIG. 32 is a schematic illustration of another embodiment of theinvention and depicting the relationship between sections of a sutureand sections of a suture retainer;

[0045]FIGS. 33A-33B are schematic illustrations of another embodiment ofthe invention and depicting the relationship between sections of asuture and sections of a suture retainer;

[0046]FIGS. 34A-34B are schematic illustrations of another embodiment ofthe invention and depicting the relationship between sections of asuture and the suture retainer;

[0047]FIGS. 35A-35B are schematic illustrations of another embodiment ofthe invention and depicting the relationship between sections of asuture and the suture retainer;

[0048]FIGS. 36A-36C are schematic illustrations of exemplary shaped hornconfigurations for use with the suture retainer of FIG. 35;

[0049]FIGS. 37A-37B are schematic illustrations of another embodiment ofthe invention and depicting the relationship between sections of asuture and the suture retainer;

[0050]FIG. 38A-38B are schematic illustrations of another embodiment ofthe invention and depicting the relationship between sections of asuture and the suture retainer;

[0051]FIGS. 39A-39B are schematic illustrations of a tissue retainer ofthe present invention;

[0052]FIG. 40 is a fragmentary schematic illustration depicting themanner in which a suture and an suture retainer are positioned relativeto body tissue;

[0053]FIG. 41 is an enlarged schematic illustration of the retainer ofFIG. 40;

[0054]FIG. 42 is an exploded schematic pictorial illustration depictingthe construction of a base section and cover section of the retainer ofFIGS. 40 and 41;

[0055]FIG. 43 is an exploded schematic pictorial illustration, furtherillustrating the construction of the base and cover sections of theretainer;

[0056]FIG. 44 is an exploded schematic pictorial illustration, furtherillustrating the construction of the base and cover sections of theretainer;

[0057]FIG. 45 is an exploded schematic pictorial illustration furtherillustrating the construction of the base and cover sections of theretainer;

[0058]FIG. 46 is a schematic sectional view depicting the relationshipbetween the base and cover sections of the retainer of FIGS. 40-45 withportions of the suture disposed in passages in the retainer; and

[0059]FIG. 47 is a schematic fragmentary sectional view, generallysimilar to FIG. 46, depicting the manner in which end portions ofprojections on the cover section of the retainer are bonded to bottomportions of recesses in the base section of the retainer;

[0060]FIG. 48 is a schematized sectional view of an embodiment of theapparatus of FIG. 25 for applying ultrasonic vibratory energy to asuture retainer;

[0061]FIG. 49 is a schematic pictorial illustration of one embodiment ofthe applicator assembly of FIG. 48;

[0062]FIG. 50 is an enlarged fragmentary schematic pictorialillustration of a portion of the applicator assembly of FIG. 49,illustrating a trigger and spring housing;

[0063]FIG. 51 is an enlarged fragmentary schematic illustration of anend portion of the applicator assembly of FIG. 49;

[0064]FIG. 52 is a schematic illustration of a sleeve member for theapparatus of FIG. 48;

[0065]FIG. 53 is a schematic illustration of the sleeve member on theapparatus of FIG. 48;

[0066]FIG. 54 is a sectional view of the distal portion of the apparatusof FIG. 53 showing the sleeve member in a closed position;

[0067]FIG. 55 is a sectional view of the distal portion of the apparatusof FIG. 53 showing the sleeve member in an open position;

[0068]FIG. 56 is a perspective view of an energy application device ofthe present invention;

[0069]FIG. 57 is a perspective view of a handle assembly of the energyapplication device of FIG. 56;

[0070]FIG. 58 is a perspective view of an end portion of the handleassembly of FIG. 57;

[0071]FIG. 59 is a perspective view of a controller assembly of theenergy application device of FIG. 56;

[0072]FIG. 60 is a sectional view of the end portion of the controllerassembly of FIG. 59;

[0073]FIG. 61 is a sectional perspective view of the latch assembly ofthe energy application device of FIG. 56;

[0074]FIG. 62 is a sectional perspective view of the handle andcontroller assemblies of the energy application device of FIG. 56;

[0075]FIG. 63 is a sectional perspective view of the controller biasmember of the energy application device of FIG. 56;

[0076]FIG. 64 is a sectional perspective view of the suture tensionersof the energy application device of FIG. 56;

[0077]FIG. 65 is a perspective view of a suture retainer for use withthe energy application device of FIG. 56;

[0078]FIG. 66 is a perspective view of a upper section of the sutureretainer of FIG. 65;

[0079]FIG. 67 is a perspective view of a lower section of the sutureretainer of FIG. 65;

[0080]FIG. 68 is a front view of the lower section of the sutureretainer of FIG. 65; and

[0081]FIG. 69 depicts the suture retainer of FIG. 65 positioned withinan end portion of the energy application device of FIG. 56.

DETAILED DESCRIPTION OF THE INVENTION

[0082] Embodiment of FIGS. 1-3

[0083] A tissue securing system 30 (FIG. 1) includes a suture 32 and asuture retainer or crimp 34. The suture 32 includes left and rightsections 38 and 40 which are interconnected by a connector section 42.The suture retainer 34 grips the left and right sections 38 and 40 ofthe suture 32.

[0084] The tissue securing system 30 is used in a sterile, operatingroom environment to secure upper and lower layers 46 and 48 of soft,human body tissue in linear apposition with each other. Thus, the twolayers 46 and 48 of human body tissue are approximated and held againstmovement relative to each other by the suture 32. Although the twolayers 46 and 48 of body tissue have been schematically illustrated inFIG. 1 as being spaced apart from each other, they are held in aside-by-side relationship with each other and pressed together bytightening the tissue securing system 30. Pressing the two layers 46 and48 together with the tissue securing system 30 promotes healing of thetissue.

[0085] Although the tissue securing system 30 has been illustrated inFIG. 1 as being used to hold layers of soft tissue in linear appositionwith each other, it is contemplated that the tissue securing system maybe used in many different locations in a patient's body to securetissue. For example, the tissue securing system 30 could be utilized tosecure soft tissue, such as a ligament or tendon, against movementrelative to a bone. Alternatively, the tissue securing system 30 couldbe utilized to interconnect portions of a flexible conduit, such as ablood vessel or intestine. It should be understood that the tissuesecuring system 30 may be used with either hard body tissue, or softbody tissue, or both hard and soft body tissue.

[0086] If desired, a force distribution member, such as a button, couldbe utilized between the connector section 42 of the suture 32 and thelower layer 48 of body tissue. The force distribution member woulddistribute force over a relative large area of the lower layer 48 ofbody tissue. Similarly, a force distribution member, such as a button,could be utilized between the upper layer 46 of soft tissue and the leftand right sections 38 and 40 of the suture 32 and the suture retainer34.

[0087] It is also contemplated that the suture 32 could extend through asuture anchor and/or be connected with body tissue in a manner similarto that disclosed in U.S. Pat. Nos. 5,584,862; 5,549,631; and/or5,527,343. Of course, the suture 32 could be connected with body tissuein a different manner if desired. For example, the connector section 42could be eliminated. If this is done, the left section 38 of the suture32 could be connected with one suture anchor and the right section 40 ofthe suture could be connected with a second suture anchor.

[0088] Although the sections 38 and 40 of the suture 32 could extendstraight through the suture retainer 34, in the illustrated embodimentof the invention, the sections 38 and 40 of the suture 32 are wrappedaround portions of the suture retainer 34. Thus, the left section 38 ofthe suture 32 is wrapped around a portion 52 (FIG. 2) of the sutureretainer 34. Similarly, the right section 40 of the suture is wrappedaround a portion 54 of the suture retainer 34.

[0089] In the illustrated embodiment of the invention, the left section38 of the suture 32 is wrapped for more than a complete turn around theportion 52 of the suture retainer and the right section 40 of the sutureis wrapped for more than a complete turn around the portion 54 of thesuture retainer. However, if desired, wrapping of the sections 38 and 40of the suture 32 around the suture retainer 34 could be omitted or eachof the sections of the suture could be wrapped for less than onecomplete turn around a portion of the suture retainer.

[0090] When the sections 38 and 40 of the suture 32 are wrapped aroundthe portions 52 and 54 of the suture retainer 34, a plurality of bendsare formed in each of the sections of the suture. Thus, bends 58, 60, 62and 64 are formed in the section 38 of the suture 32 as it is wrappedaround the portion 52 of the suture retainer 34. Similarly, bends 66,68, 70 and 72 are formed in the section 40 of the suture 32 as it iswrapped around the portion 54 of the suture retainer 34. Of course, agreater number of bends would be formed in each of the sections 38 and40 of the suture 32 if they were wrapped a greater number of timesaround the suture retainer 34.

[0091] Although the suture retainer 34 could have many differentconstructions and configurations, in the illustrated embodiment of theinvention, the suture retainer 34 is integrally formed as one piece andhas a spherical configuration. A cylindrical central passage 76 extendsaxially through the suture retainer 34 between upper and lower (asviewed in FIG. 2) polar regions of the spherical suture retainer. Thetwo sections 38 and 40 of the suture 32 extend through the passage 76.The suture retainer 34 is formed separately from the suture 32 and isinitially disconnected from the suture.

[0092] In the illustrated embodiment of the invention, two lengths ofthe left suture section 38 and two lengths of the right suture section40 extend through the passage 76 as a result of the wrapping of thesections of the suture around the portions 52 and 54 of the sutureretainer 34. However, the two sections 38 and 40 of the suture 32 couldextend straight through the passage 76 without being wrapped around theportions 52 and 54 of the suture retainer 34. If this was done, only asingle length of the left section 38 of the suture 32 would be disposedin the passage 76 adjacent to a single length of the right section 40 ofthe suture 32. Of course, if the sections 38 and 40 of the suture 32were wrapped around the portions 52 and 54 of the suture retainer for agreater number of turns, a greater number of lengths of the sections 38and 40 of the suture 32 would extend through the passage 76.

[0093] In the illustrated embodiment of the suture retainer 34, a pairof grooves or recesses 80 and 82 extend radially inward from a sphericalouter side surface 84 of the suture retainer 34. The grooves or recesses80 and 82 are relatively deep so that the portions 52 and 54 of thesuture retainer around which the suture is wrapped are relativelyslender. This results in relatively short lengths of the sections 38 and40 of the suture being disposed in engagement with the outer sidesurface of the suture retainer 34 adjacent to the upper and lower polarregions of the suture retainer.

[0094] In the embodiment of the invention illustrated in FIG. 2, thegrooves or recesses 80 and 82 extend inward from the outer side surface84 of the suture retainer 34. The depth of the grooves or recesses 80and 82 varies along the vertical (as viewed in FIG. 2) length of thegrooves. However, it is contemplated that the grooves 80 and 82 could beconstructed so as to have a uniform depth throughout their length. Ifthis was done, the grooves 80 and 82 would have an arcuate configurationwith centers of curvature which are coincident with the center ofcurvature of the spherical outer side surface 84 of the suture retainer34.

[0095] Rather than opening radially outward to the outer side surface 84of the suture retainer 34, the grooves 80 and 82 could be undercut toenclose the portions of the suture 32 disposed in the grooves. It iscontemplated that the grooves could have any one of the grooveconfigurations disclosed in U.S. Pat. No. 6,010,525. The disclosure fromthe aforementioned U.S. Pat. No. 6,010,525 is incorporated herein in itsentirety by this reference thereto. Alternatively, the grooves 80 and 82could be formed as passages which extend through the suture retainer 34parallel to and spaced apart from the central passage 76.

[0096] It is contemplated that the suture retainer 34 may be formed ofmany different materials. However, it is contemplated that it will bepreferred to form the suture retainer 34 of a biodegradable polymer. Onebiodegradable polymer which may be utilized is polycaperlactone.Alternatively, the suture retainer 34 could be formed of polyethyleneoxide terephthalate or polybutylene terephthalate. The suture retainer34 could be formed as a polyhydroxyalkanoate if desired. It is alsocontemplated that other biodegradable or other bioerodible copolymerscould be utilized if desired.

[0097] Although it is preferred to form the suture retainer 34 of abiodegradable material, the suture retainer could be formed of amaterial which is not biodegradable. For example, the suture retainer 34could be formed of an acetyl resin, such as “Delrin” (trademark).Alternatively, the suture retainer 34 could be formed of apara-dimethylamino-benzenediazo sodium sulfonate, such as “Dexon”(trademark). If desired, the suture retainer 34 could be formed ofnylon. Additionally, the suture retainer 34 may be made of a heat shrinkmaterial.

[0098] The suture 32 may be formed of the same material as the sutureretainer 34 or of a different material. The suture 32 may be formed ofnatural or synthetic materials. The suture 32 may be a monofilament ormay be formed of a plurality of interconnected filaments. The suture 32may be biodegradable or non-biodegradable. It is contemplated that thesuture retainer 34 could be utilized in association with forcetransmitting elements other than a suture. It is believed that it may bepreferred to form the suture 32 of the same material as the sutureretainer 34.

[0099] In accordance with a feature of the present invention, ultrasonicvibratory energy is utilized to cause the suture retainer 34 to grip thesuture 32. The ultrasonic vibratory energy is at a frequency above thatwhich can normally be detected by the human ear, that is, above 16 to 20kilohertz. Although there are a wide range of frequencies which may beutilized, it is believed that it will be desirable to use ultrasonicenergy having a frequency of between 20 kilohertz and 70 kilohertz.However, higher frequency vibratory energy could be utilized if desired.

[0100] The ultrasonic vibratory energy may be continuously applied,pulsed or modulated in various fashions. Any one of many knowntransducers may be utilized to change electrical energy into mechanicalvibrations having an ultrasonic frequency. The transducers may bepiezoelectric, ferroelectric, or magnetostrictive. One commercial sourceof apparatus which may be utilized to provide ultrasonic vibratoryenergy is Dukane Corporation, Ultrasonics Division, 2900 Dukane Drive,St. Charles, Ill. Of course, there are other sources of apparatus whichcan be utilized to provide ultrasonic vibratory energy.

[0101] The ultrasonic vibratory energy creates frictional heat at theareas where the suture retainer 34 and suture 32 are disposed inengagement with each other. The frictional heat provided by theultrasonic vibratory energy is effective to heat the material of thesuture retainer 34 into its transition temperature range while thematerial of the suture 32 remains at a temperature close to or below itstransition temperature range. For example, the suture 32 may be formedof a material having a transition temperature range which is above 190degrees Celsius. The suture retainer 34 may have a transitiontemperature range which, for the most part, is at a temperature below190 degrees Celsius.

[0102] However, it should be understood that at least a portion or eventhe entire transition temperature range for the suture 32 could beco-extensive with the transition range for the suture retainer 34. Infact, the transition temperature range of the suture 32 could extendbelow the transition temperature range of the suture retainer 34.However, it is believed that it may be preferred to have the transitiontemperature range for the suture 32 above at least a portion of thetransition temperature range of the suture retainer 34.

[0103] Once the material of the suture retainer 34 has been heated intoits transition temperature range by the ultrasonic vibratory energy, theplastic material of the suture retainer 34 loses its rigidity andbecomes soft and viscous. The softened material of the suture retaineris moldable and flows, when subjected to pressure, around the suture 32without significant deformation of the suture. However, the temperaturerange into which the suture 32 is heated and the pressure appliedagainst the suture may result in some deformation of the suture.

[0104] Although it is contemplated that the suture 32 and sutureretainer 34 could be made of many different materials, the suture andsuture retainer may be formed of a plastic material which is abiopolymer. For example, the suture 32 and/or suture retainer 34 may beformed of polyglycolide which is commercial available under thetrademark “Dexon”. Polyglycolide is a crystalline material that melts atabout 225° Celsius. However, the suture could be formed of aglycolide-based copolymer which is commercially available under thetrademark “Vicryl”.

[0105] The suture retainer 34 is also made of a plastic material whichmay be a biopolymer. For example, the suture retainer 34 may be made ofpolydellactide. The transition temperature of polydellactide will varydepending upon the specific characteristics of the material. However, asuture retainer 34 formed of polydellactide may have a transitiontemperature range of about 75° Celsius to about 120° Celsius. Othermaterials which may be utilized for forming the suture 32 and/or sutureretainer 34 are disclosed in U.S. Pat. No. 5,735,875. The disclosure inthe aforementioned U.S. Pat. No. 5,735,875 is hereby incorporated hereinin its entirety by this reference thereto.

[0106] In order to promote a bonding of the material of the sutureretainer 34 to the suture 32, both the suture and suture retainer may beformed of the same amorphous thermoplastic material. For example, boththe suture 32 and suture retainer 34 may be formed of apolyhydroxy-alkanoate. Alternatively, both the suture 32 and sutureretainer 34 may be formed of nylon. It is contemplated that the suture32 and suture retainer 34 could be formed of different amorphouspolymers which are similar, that is, have the same or similar chemicalproperties.

[0107] When the ultrasonic vibratory energy is to be applied to thesuture retainer 34, a supportive member or anvil 90 (FIG. 3) ispositioned in engagement with one side of the suture retainer 34. A hornor acoustic tool 92 is positioned in engagement with the opposite sideof the suture retainer 34. Force, indicated schematically by arrows 96and 98 in FIG. 3, is applied against the suture retainer 34 by the anvil90 and horn 92.

[0108] The horn is vibrated, horizontally as viewed in FIG. 3, at a ratein excess of 20 kilohertz. Although the horn 92 may be vibrated at anydesired frequency within range of 20 kilohertz to 70 kilohertz, it isbelieved that it may be desirable to vibrate the horn 92 at a rate whichis close to or greater than 70 kilohertz. The horn 92 is vibrated for adwell time which is sufficient to transmit enough ultrasonic vibratoryenergy to the suture retainer 34 to heat at least a portion of thematerial of the suture retainer 34 into its transition temperaturerange.

[0109] To effect a heating of the material of the suture retainer 34,mechanical vibrations are transmitted from the horn 92 through thematerial of the retainer 34 to a location adjacent to an interfacebetween the suture 32 and the suture retainer 34. The frictional heatcreated by the ultrasonic vibratory energy transmitted to the sutureretainer from the horn 92 is sufficient to heat the material of thesuture retainer 34 at locations adjacent to the suture 32, into thetransition temperature range of the material of the suture retainer. Asthis occurs, the passage 76 and grooves 80 and 82 collapse under theinfluence of the force indicated at 96 and 98 in FIG. 3 and theultrasonic vibratory energy transmitted from the horn 92.

[0110] The vibration of the horn 92 is then interrupted and the materialof the suture retainer 34 begins to cool. The clamping force, indicatedby the arrows 96 and 98, is maintained against opposite sides of thesuture retainer 34 by the anvil 90 and horn 92 during the time whichultrasonic vibratory energy is transmitted from the horn 92 to thematerial of the suture retainer 34. After interruption of thetransmission of ultrasonic vibratory energy, the clamping force,indicated schematically by the arrows 96 and 98 and applied by the anvil90 and horn 92, is maintained for a predetermined amount of timesufficient to allow the material of the suture retainer to cool and bondto both itself and the suture 32.

[0111] If desired, the force, indicated schematically by the arrows 96and 98 in FIG. 3, applied by the anvil 90 and horn 92 to the sutureretainer 34 may be increased as the transmission of ultrasonic vibratoryenergy to the suture retainer 34 from the horn 92 is interrupted. Theforce, indicated schematically by the arrows 96 and 98 in FIG. 3, issufficient to cause the passage 76 and recesses 80 and 82 to collapse asthe suture retainer 34 is heated by ultrasonic vibratory energy andsubsequently allowed to cool.

[0112] The length of time for which ultrasonic vibratory energy istransmitted to the suture retainer 34 may vary as a function of theamplitude and frequency of the ultrasonic vibratory energy transmittedto the suture retainer. It is contemplated that the frequency of theultrasonic vibratory energy will be in a range of between 20 kilohertzand 70 kilohertz. It is contemplated that the amplitude of theultrasonic vibrations may vary within a range of 0.0008 inches to 0.0050inches depending upon the design of the suture retainer 34 and thematerial forming the suture retainer.

[0113] It is also contemplated that the force, indicated schematicallyby the arrows 96 and 98, applied against the suture retainer 34 may varydepending upon the construction of the suture retainer 34 and thematerial forming the suture retainer. For example, a force ofapproximately 1-20 pounds may be applied against the suture retainer 34by both the anvil 90 and horn 92. The amount of force applied is afunction of a number of factors, including, the material of the retainerand suture, the size of the retainer and suture, the frequency of theultrasonic vibratory energy and the duration of application of theultrasonic vibratory energy.

[0114] It is believed that the ultrasonic vibratory energy may betransmitted from the horn 92 to the suture retainer 34 for a period oftime which varies between 0.25 seconds and 1.0 second. After thetransmission of ultrasonic vibratory energy has been interrupted, theforce, indicated by the arrows 96 and 98, may continue to be applied tothe suture retainer 34 by the anvil 90 and horn 92 for approximately 1.0seconds.

[0115] The extent to which the suture retainer 34 is compressed by theforce 96 and 98 applied against the suture retainer by the anvil 90 andhorn 92 has been illustrated schematically in FIG. 3. It is contemplatedthat the distance through which the anvil 90 and horn 92 move towardeach other to compress the suture retainer 34 may be from 0.010 inchesto 0.050 inches. Of course, the distance through which the sutureretainer 34 is compressed by the anvil 90 and horn 92 may be differentfor suture retainers having different constructions and/or formed ofdifferent materials.

[0116] It should be understood that the foregoing specific operatingcharacteristics, for example, amplitude and frequency of the ultrasonicvibratory energy transmitted from the horn 92 to the suture retainer 34,force applied against the suture retainer by the anvil 90 and horn 92,time for which force and/or ultrasonic vibratory energy is applied, andthe distance through which the suture retainer is compressed, have beenset forth herein for purposes of clarity of description. It iscontemplated that the foregoing specific numerical values will bedifferent for different embodiments of the invention and may varyextensively from the exemplary values set forth.

[0117] When the two layers 46 and 48 of body tissue are to be held inposition relative to each other by the tissue securing system 30, thesuture 32 is positioned relative to the layers of body tissue. The leftand right sections 38 and 40 of the suture 32 extend through the twolayers 46 and 48 of tissue. Although the sections 38 and 40 of thesuture 32 have been illustrated schematically in FIG. 1 as extendingthrough passages in the layers 46 and 48 of body tissue, the passagescould be omitted and the suture 32 sewn through the body tissue withoutforming passages in the body tissue.

[0118] In the embodiment of the invention illustrated in FIG. 1, thesections 38 and 40 of the suture 32 are interconnected by the connectorsection 42 which extends along one side of the layer 48 of body tissue.If desired, the sections 38 and 40 of the suture 32 could be connectedwith a single anchor embedded in either hard or soft body tissue.Alternatively, a separate anchor could be provided for each of thesections 38 and 40 of the suture 32. These anchors could be embedded inthe body tissue or disposed adjacent to one side of the body tissue.

[0119] When the suture 32 has been positioned relative to the two layers46 and 48 of body tissue, the two layers of body tissue are pressedagainst each other in linear apposition. The suture retainer 34 is thenconnected with the suture 32. When the suture retainer 34 is to beconnected with the suture 32, the left (as viewed in FIG. 2) section 38of the suture is inserted through the central passage 76 in the sutureretainer 34. The left section 38 of the suture 32 is then wrapped aroundthe portion 52 of the suture retainer 34 and again inserted through thecentral passage 76.

[0120] Similarly, the right section 40 of the suture 32 is insertedthrough the central passage 76 and wrapped around the portion 54 of thesuture retainer 34. The right section 40 of the suture is then insertedthrough the central passage 76 for a second time. This results in thesuture 32 being connected with the suture retainer 34 in the mannerillustrated schematically in FIG. 2.

[0121] The suture retainer 34 is then moved downward (as viewed in FIGS.1 and 2) along the suture 32 toward the upper layer 46 of body tissue.The suture 32 is tensioned with a predetermined force during downwardmovement of the suture retainer 34 toward the body tissue. As the sutureretainer 34 moves downward (as viewed in FIGS. 1 and 2) along the suture32 toward the upper layer 46 of body tissue, the turns formed in thesections of the suture around the portions 52 and 54 of the sutureretainer 34 move downward toward the body tissue. Thus, the bends 58-64in the section 38 of the suture 32 and the bends 66-72 in the section 40of the suture 32 move along the suture toward the upper layer 46 of bodytissue with the suture retainer 34.

[0122] As the suture retainer 34 is moved along the suture 32 toward theupper layer 46 of body tissue, a predetermined tension, indicated byarrows 102 and 104 in FIG. 3, is maintained in the sections 38 and 40 ofthe suture 32. The magnitude of the tension forces 102 and 104 in thesections 38 and 40 of the suture 32 is selected as a function of thecharacteristics of the layers 46 and 48 of body tissue and as a functionof the strength of the suture.

[0123] As the suture retainer 34 moves downward (as viewed in FIGS.1-3), the leading portion of the suture retainer moves into engagementwith the upper layer 46 of body tissue (FIG. 3). The suture retainer 34is then pressed against the upper layer 46 of body tissue. If desired, aforce distribution member, such as a button, could be provided betweenthe suture retainer 34 and the body tissue 46.

[0124] The suture retainer 34 is pressed downward against the bodytissue 46 with a predetermined force, indicated schematically by anarrow 106 in FIG. 3, while a predetermined tension, indicatedschematically by the arrows 102 and 104, is maintained in the suture 32.The force transmitted from the suture 32 and suture retainer 34 to thelayers 46 and 48 of body tissue presses them together and, to someextent, compresses the layers of body tissue. This results in the layersof body tissue being held in linear apposition and being compressed topromote healing of the layers 46 and 48 of body tissue.

[0125] The force, indicated by the arrows 102 and 104, with which thesections 38 and 40 of the suture 32 are tensioned, may vary dependingupon the material from which the suture is constructed and the size ofthe suture. By consulting a chart, a surgeon can select a suture sizeand strength suitable for a particular use. Thus, a relatively largesuture having substantial strength may be selected when body tissue isto be connected with a bone or when portions of a bone are to beinterconnected by the suture. On the other hand, a relatively smallsuture size having a relatively small strength may be selected whendelicate body tissue, such as stomach or intestinal tissue, is to beinterconnected with the suture. The tension forces 102 and 104 in thesections 38 and 40 are determined as a function of the strength 32 ofthe suture and the characteristics of the body tissue through which thesuture extends

[0126] The suture 34 is pressed against the body tissue with a forcewhich is also a function of the size and strength of the suture 32 andthe characteristics of the body tissue 46 and 48. One way in which forcewith which the suture 32 is tensioned and with which the suture 34 ispressed against body tissue is disclosed in U.S. Pat. No. 6,159,234filed Jul. 7, 1999 by Peter M. Bonutti et al. and entitled “Method andApparatus for Securing a Suture”. The disclosure in the aforementioned'234 patent is hereby incorporated herein by this reference thereto.

[0127] After the suture retainer 34 has been pressed against the bodytissue with a predetermined force and the suture 32 tensioned with apredetermined force to compress the layers 46 and 48 of body tissue,ultrasonic vibratory energy is applied to the suture retainer. To applythe ultrasonic vibratory energy to the suture retainer 34, the anvil 90(FIG. 3) is positioned in engagement with one side of the sutureretainer and the horn 92 is positioned in engagement with the oppositeside of the suture retainer. The anvil 90 and horn 92 are urged towardeach other with a predetermined force, indicated schematically by thearrows 96 and 98 in FIG. 3.

[0128] The specific magnitude of the force 96 and 98 will vary dependingupon the composition of the suture retainer 34 and the construction ofthe suture retainer. In addition, the magnitude of the force 96 and 98will vary as a function of the desired extent of deformation of thesuture retainer 34. When the suture retainer 34 has been heat softenedby ultrasonic vibratory energy, the material of the suture retainer ispliable and is plastically deformed by the force applied against thesuture retainer by the anvil 90 and horn 92.

[0129] In addition to the anvil 90 and horn 92, the apparatus fortransmitting ultrasonic vibratory energy to the suture retainer 34includes a generator (not shown) which changes standard electrical powerinto electrical energy at the desired ultrasonic frequency. A transducer(not shown) changes the electrical energy into low amplitude mechanicalmotion or vibration. These vibrations are transmitted to a booster whichis used to increase or decrease the amplitude of the vibrations. Thevibrations are then transmitted to the horn 92.

[0130] The ultrasonic vibratory energy transmitted to the sutureretainer 34 from the horn 92 is converted into heat energy. When thisoccurs, the temperature of the material forming the suture retainer 34increases. The heat tends to concentrate at a boundary between thesuture 32 and the suture retainer 34. Thus, the heat tends toconcentrate in the areas where the suture 32 engages the grooves 80 and82 and the passage 76 (FIG. 2).

[0131] As the temperature of the suture retainer 34 increases, thematerial of the suture retainer is heated into the transitiontemperature range and softens. However, the material of the sutureretainer 34 does not melt and become liquid. As the material of thesuture retainer 34 softens, the forces 96 and 98 (FIG. 3) appliedagainst the suture retainer cause the material of the suture retainer toflow or ooze around and engage the suture 32.

[0132] As the ultrasonic vibratory energy is effective to heat softenthe material of the suture retainer 34, the grooves 80 and 82 close,that is, collapse. As the grooves 80 and 82 close, the central passage76 also closes. As the grooves 80 and 82 and central passage 76 close,the softened material of the suture retainer 34 moves into engagementwith the suture (FIG. 3).

[0133] The viscous material of the suture retainer 34 engages the suture32 and bonds to the suture without significant deformation of thesuture. The materials of the suture 32 and suture retainer 34 should bechemically compatible so that a molecular bond can be establishedbetween the suture retainer and the suture. Like materials, that ismaterials having chemical properties which are the same or very similarwill usually bond together. However, dissimilar materials may bond iftheir melt temperatures are reasonably close and they are of likemolecular structure. Generally speaking, amorphous polymers are readilybonded to each other.

[0134] The suture retainer 34 is formed separately from the suture 32.As the material of the suture retainer 34 bonds to the suture 32, thesuture retainer 34 becomes fixedly connected to the suture.

[0135] If desired, heat may be transmitted directly to the sutureretainer 34 during the transmission of ultrasonic vibratory energy tothe suture retainer. The heat may be transmitted from a heating elementdisposed in the anvil 90 and/or the horn 92. Alternatively, a separatemember could be utilized to transmit heat to the suture retainer 34.

[0136] In the embodiment of the invention illustrated in FIGS. 1-3, theanvil 90 and horn 92 have a configuration which corresponds to thearcuate configuration of the spherical outer side surface 84 (FIG. 2) ofthe suture retainer 34. The anvil 90 and horn 92 are configured so as toengage the material of the suture retainer 34 and to be spaced from thesuture 32. This is to prevent excessive heating of the material of thesuture 32 by the direct application of ultrasonic vibratory energy tothe suture.

[0137] Embodiment of FIG. 4

[0138] In the embodiment of the invention illustrated in FIGS. 1-3,sections 38 and 40 of the suture 32 are wrapped around portions 52 and54 of the suture retainer 34. In the embodiment of the inventionillustrated in FIG. 4, a single section of the suture extends straightthrough a passage in the suture retainer. Since the embodiment of theinvention illustrated in FIG. 4 is generally similar to the embodimentof the invention illustrated in FIGS. 1-3, similar terminology will beutilized to designate similar components. It should be understood thatone or more of the features of any of the various embodiments of theinvention disclosed herein may be used with the embodiment of theinvention illustrated in FIG. 4.

[0139] In the embodiment of the invention illustrated in FIG. 4, asuture 112 is inserted through upper and lower (as viewed in FIG. 4)layers 114 and 116 of human body tissue in a sterile operating roomenvironment. A first or inner end portion 118 of the suture 112 isconnected with a suture anchor 120. The suture anchor 120 could have anydesired construction, including the construction disclosed in U.S. Pat.Nos. 5,584,862; 5,549,631; and/or 5,527,343. However, the illustratedembodiment of the suture anchor 120 is a circular disc or button havinga pair of central openings around which the end portion 118 of thesuture 112 is tied.

[0140] The suture 112 extends straight through the lower layer 116 andupper layer 114 of body tissue. The two layers of body tissue aredisposed in linear apposition with each other and are compressed betweenthe suture anchor 120 and a suture retainer 124. The upper and lowerlayers 114 and 116 of body tissue are compressed by force appliedagainst the body tissue by the suture retainer 124 and suture anchor120. By having the layers 114 and 116 of body tissue approximated witheach other and by pressing the layers of tissue together, healing of thetissue is promoted.

[0141] Although the layers 114 and 116 are layers of soft body tissue,the suture 112, suture anchor 120, and suture retainer 124 could be usedwith hard body tissue in the manner disclosed in U.S. Pat. No.5,921,986. Alternatively, the suture 112, suture anchor 120, and sutureretainer 124 could be used to connect soft body tissue with hard bodytissue.

[0142] The suture retainer 124 has a spherical configuration and isformed separately from the suture 112. A cylindrical passage 126 extendsaxially through the suture retainer 124. Although the suture 112 extendsstraight through the passage 126 in the suture retainer 124, bendsand/or loops could be formed in the suture 112 around the sutureretainer 124.

[0143] The suture retainer 124 is formed of one piece of sphericalpolymeric material having a relatively low coefficient of friction. Thesuture retainer 124 may be formed of many different materials. However,it is believed that it may be preferred to form the suture retainer 124of a biodegradable polymer such as polycaperlactone orpolyhydroxyalkanoate. It is contemplated that other biodegradable orbioerodible polymers could be utilized if desired. It is believed thatit may be preferred to form the suture retainer 124 of an amorphousthermoplastic material.

[0144] The suture 112 may be a monofilament or may be formed of aplurality of interconnected filaments. The suture 112 may bebiodegradable or non-biodegradable. It is believed that it will bepreferred to form the suture 112 of the same material as the sutureretainer 124. However, the suture 112 could be formed of a materialwhich is different than the material of the suture retainer. The suture112 may be formed of an amorphous thermoplastic having chemicalproperties which are the same or similar to the chemical properties ofthe suture retainer 124. For example, both the suture retainer 124 andthe suture 112 may be formed of the same biodegradable polymer, such aspolycaperlactone or polyhydroxyalkanoate.

[0145] The suture 112 is tensioned with a force which is a function ofthe size and strength of the suture. In addition, the suture retainer124 is pressed against the upper layer 114 of body tissue with a forcewhich is a function of the size and strength of the suture 112. Althoughthe suture retainer 124 is disposed in direct engagement with and ispressed against an outer side surface of the upper layer 114 of bodytissue, a force distribution member or button could be positionedbetween the suture retainer and the upper layer 114 of body tissue.

[0146] The suture 112 is tensioned by a force application assembly 130which is connected with a second or outer end portion 132 of the suture112. The force application assembly 130 includes a transducer or loadcell 134 which provides an output signal indicative of a force,indicated schematically at 136 in FIG. 4, which is applied to the secondor outer end portion 132 of the suture 112. The force 136 has amagnitude which is a function of the size and strength of the suture 112and the characteristics of the body tissue with which the suture isassociated, that is, the upper layer 114 and lower layer 116 of bodytissue.

[0147] The suture retainer 124 is pressed against the body tissue with aforce which is also a function of the strength and size of the suture112. A force application member 140 is used to apply force against thesuture retainer 124. The force application member 140 has a cylindricalopening 142 which extends through the force application member.

[0148] The suture 112 extends through the opening 142 in the forceapplication member 140. A slot may be formed in the force applicationmember 140 to enable the suture to be moved into the opening 142.Alternatively, the suture 112 could be inserted through the opening 142before the end portion of the suture is connected with the forceapplication assembly 130.

[0149] Forces, indicated schematically at 146 and 148 in FIG. 4, areapplied against opposite end portions 150 and 152 of the forceapplication member 140 to press the suture retainer 124 against theupper layer 114 of body tissue or against a force transmitting memberdisposed between the suture retainer 124 and the upper layer 114 of bodytissue. The combined force indicated schematically by the arrows 146 and148 in FIG. 4, is a function of the size and strength of the suture 112and the characteristics of the layers 114 and 116 of body tissue. It iscontemplated that the combined forces 146 and 148 may be equal to theforce 136. Alternatively, the summation of the forces 146 and 148 couldexceed the force 136 or be less than the force 136.

[0150] The suture retainer 124 slides downward (as viewed in FIG. 4)along the suture 112 under the influence of the force application member140. At this time, the suture 112 is tensioned by the force applicationassembly 130 so that the portion of the suture extending between thesuture anchor 120 and the force application assembly 130 is straight, asillustrated in FIG. 4. However, at this time, the force which is appliedto the outer end portion 132 by the force transmitting assembly may besubstantially less than the force which is indicated schematically bythe arrow 136 in FIG. 4.

[0151] After the suture retainer 124 has been moved along the suture 112to the position illustrated in FIG. 4, the force applied against thesuture retainer by the force application member 140 is increased. At thesame time, the force applied to the outer end portion 132 of the suture112 by the force application assembly 130 is increased. The forceapplied against the suture retainer by the force application member 140is increased until the force, indicated schematically by the arrows 146and 148 in FIG. 4, is equal to a predetermined force which is a functionof the strength of the suture 112 and the characteristics of the layers114 and 116 of body tissue. At the same time, the force applied to theouter end portion 132 of the suture 112 by the force applicationassembly 130 is increased to the force indicated schematically by thearrow 136 in FIG. 4. As was previously mentioned, the force indicated bythe arrow 136 is a predetermined function of the strength of the suture112 and the characteristics of the layers 114 and 116 of body tissue.

[0152] While the suture 112 is being pulled straight under the influenceof tension in the suture due to the force 136 and while the sutureretainer 124 is being pressed against the upper layer 114 of body tissueor against a suitable force distribution member, the suture retainer 124is heated to grip the suture 112. In accordance with one of the featuresof the invention, the suture retainer 124 is heated by the applicationof ultrasonic vibratory energy to the suture retainer. The ultrasonicvibratory energy is converted into heat by the molecules of the sutureretainer 124. Thus, the mechanical ultrasonic vibrations applied againstthe suture retainer 124 cause molecular vibration of the material of thesuture retainer and a heating of the suture retainer.

[0153] When a portion of the material forming the suture retainer 124has been heated into its transition temperature range, the applicationof ultrasonic vibratory energy to the suture retainer 124 isinterrupted. Heating the material forming the suture retainer 124 causesthe material to lose its rigidity and soften. The material of the sutureretainer 124 is not melted and does not become liquid by being heatedinto its transition temperature range. The softened material of thesuture retainer 124 bonds to the suture 112 without significantdeformation of the suture.

[0154] To apply ultrasonic vibratory energy to the suture retainer 124,a support member or anvil 160 engages one side, that is the left side asviewed in FIG. 4, of the suture retainer 124. At the same time, a hornor acoustic tool is pressed against the opposite or right side (asviewed in FIG. 4) of the suture retainer 124.

[0155] The anvil 160 and horn 162 are pressed against opposite sides ofthe suture retainer 124 with predetermined forces, indicatedschematically by arrows 164 and 166 in FIG. 4. After the suture retainer124 has been firmly clamped between the anvil 160 and horn 162, the hornis vibrated with an ultrasonic frequency, that is with a frequency whichis greater than 20 kilohertz. It is contemplated that the horn 162 maybe vibrated at a selected frequency within a range of ultrasonicfrequencies which extends between 20 kilohertz and 70 kilohertz.Although the particular ultrasonic frequency with which the horn 162 isvibrated will vary depending upon the composition and construction ofthe suture retainer 124, it is believed that it may be preferred tovibrate the horn 162 with a frequency which is close to or greater than70 kilohertz.

[0156] The mechanical vibrations applied to the suture retainer 124 bythe horn 162 are effective to heat a portion of the material of thesuture retainer 124 into the transition temperature range. The heattends to concentrate on the portion of the suture retainer 124 adjacentto the passage 126 and the suture 112. When the material of the sutureretainer 124 adjacent to the suture 112 has been heated into itstransition temperature range, the application of ultrasonic vibratoryenergy to the suture retainer 124 is interrupted. The forces 164 and 166are effective to close or collapse the passage 126 and to press thesoftened material of the suture retainer 124 against the suture 112.

[0157] Although the application of ultrasonic vibratory energy to thesuture retainer 124 is interrupted, the anvil 160 and horn 162 continueto apply the forces 164 and 166 against the softened material of thesuture retainer. If desired, the forces 164 and 166 may be increasedwhen the application of ultrasonic vibratory energy to the sutureretainer 124 by the horn 162 is interrupted. The forces 164 and 166firmly press the heat-softened material of the suture retainer 124 intothe passage 126 to collapse the passage. The heat softened material ofthe suture retainer 124 is plastically deformed and pressed against thesuture 112 by the forces 164 and 166 applied against the suture retainerby the anvil 160 and horn 162.

[0158] The forces 164 and 166 are maintained for a sufficient period oftime to enable the material of the suture retainer 124 flow about thesuture 112, securing the suture 112, without significant deformation ofthe suture. Once this has been achieved, application of the forces 164and 166 is interrupted and the anvil 160 and horn 162 are withdrawn. Theforce application member 140 may then be disengaged from the sutureretainer and the force application assembly 130 disconnected from theouter end portion 132 of the suture 112.

[0159] When the layers 114 and 116 of body tissue are to beinterconnected with the suture 112, suture anchor 120 and sutureretainer 124, the upper layer 114 is moved into apposition with thelower layer 116 of body tissue. The suture 112 is then connected withthe suture anchor 120 and is inserted through the layers 114 and 116 ofbody tissue with a suitable needle. The outer end portion 132 of thesuture 112 is then inserted through the passage 126.

[0160] The suture retainer 124 is then moved along the suture 112 intoengagement with the upper layer 114 of body tissue. The forceapplication member 140 is utilized to transmit the forces 146 and 148 tothe suture retainer 124 to press the suture retainer against the upperlayer 114 of body tissue. This results in the two layers 114 and 116 ofbody tissue being pressed firmly together between the suture retainer124 and suture anchor 112. The forces 146 and 148 are transmitted to thesuture retainer 124 through the force application member 140. The suture112 is tensioned with a force 136 by the force application assembly 130.

[0161] The anvil 160 and horn 162 then compress the suture retainer 124under the influence of the forces 164 and 166. Ultrasonic vibratoryenergy is transmitted to the suture retainer. Upon heating and softeningof at least a portion of the material of the suture retainer 124, thetransmission of ultrasonic energy to the suture retainer is interruptedand a securing of the suture 112 by the suture retainer occurs. Afterthe suture retainer 124 has firmly gripped the suture 112, theapplication of the forces 164 and 166 is interrupted.

[0162] In the foregoing explanation of the manner in which the layers114 and 116 of body tissue are secured by the use of the suture 112,suture anchor 120 and suture retainer 124, the suture retainer has beenheated by only the application of ultrasonic vibratory energy to thesuture retainer. However, it is contemplated that heat energy could betransmitted directly to the suture retainer along with the ultrasonicvibratory energy. If this was to be done, a heating element could beprovided in the anvil 160 and/or horn 162. If desired, a separateheating element could engage the suture retainer to transmit the heat tothe suture retainer separately from the anvil 160 and horn 162.

[0163] It is believed that it probably will be preferred to have theanvil 160 and horn 162 engage the suture retainer 124 at locationsspaced from the suture 112 to prevent excessive heating of the materialof the suture. If desired, protective collars could be provided aroundthe suture 112 at opposite ends of the passage 126.

[0164] Embodiment of FIG. 5

[0165] In the embodiment of the invention illustrated in FIG. 4, asingle section of the suture 112 extends through a single passage 126 inthe suture retainer 124. In addition, in the embodiment of the inventionillustrated in FIG. 4, ultrasonic vibratory energy is applied to thesuture retainer 124 by the horn 162 which also applies a compressiveforce 166 against the suture retainer. In the embodiment of theinvention illustrated in FIG. 5, a plurality of sections of the sutureextend through a plurality of passages in the suture retainer. Inaddition, ultrasonic vibratory energy is applied to the suture retainerby a member which is separate from the members which apply force againstopposite sides of the suture retainer. Since the suture retainer of theembodiments of the invention illustrated in FIGS. 1-4 are similar to theembodiment of the suture retainer illustrated in FIG. 5, similarterminology will be utilized to designate similar components. It shouldbe understood that one or more of the features of any of the embodimentsof the invention disclosed herein may be used with the embodiment of theinvention illustrated in FIG. 5.

[0166] A tissue securing system 174 is used in a sterile, operating roomenvironment and includes a suture 176 and a suture retainer 178. Thesuture 176 has left and right sections 182 and 184 which extend intohuman body tissue 186. The body tissue 186 may include a plurality oflayers which are approximated in linear apposition with each other inthe manner previously described in conjunction with the embodiment ofthe invention illustrated in FIG. 1.

[0167] Although the suture 176 has been illustrated in FIG. 5 inassociation with soft body tissue 186, it is contemplated that thesuture 176 could be associated with hard or hard and soft body tissue.In the embodiment of the invention illustrated in FIG. 5, the suturesections 182 and 184 are interconnected by a connector section whichengages the body tissue in the manner illustrated schematically inFIG. 1. However, it should also be understood that the suture 176 couldbe associated with a suture anchor, similar to the suture anchor 120 ofFIG. 4, if desired. Rather than being disposed in engagement with anouter side surface of a layer of body tissue, the suture anchor could beembedded in the body tissue.

[0168] The suture retainer 178 has a spherical configuration and isformed separately from the suture 176. A pair of parallel passages 190and 192 extend through the suture retainer 178 at locations offset toopposite sides of a central or polar axis of the suture retainer. Aforce transmitting member 194 is provided between the suture retainer178 and the body tissue 186.

[0169] The sections 182 and 184 of the suture 176 press against oppositesides of the force transmitting member 194. If desired, the forcetransmitting member 194 could be provided with grooves or passages toreceive the sections 182 and 184 of the suture 176. The forcetransmitting member 194 could be integrally formed as one piece with thesuture retainer 178. Both the force transmitting member 194 and sutureretainer 178 are formed separately from the suture 176.

[0170] In accordance with a feature of this embodiment of the invention,ultrasonic vibratory energy is applied to the suture retainer 178 by ahorn or acoustic tool 200. The horn 200 extends into a cylindricalpassage 202 formed in the suture retainer 178. The passage 202 extendsparallel to and is disposed midway between the passages 190 and 192which receive the sections 182 and 184 of the suture 176.

[0171] In the embodiment of the invention illustrated in FIG. 5, thehorn 200 has a generally cylindrical configuration which corresponds tothe cylindrical configuration of the passage 202. However, the horn 200and passage 202 could have different configurations if desired. Forexample, the horn 200 and passage 202 could have frustroconicalconfigurations.

[0172] A pair of force application members or anvils 206 and 208 arepressed against opposite sides of the suture retainer 178 withpredetermined forces, indicated schematically by arrows 210 and 212 inFIG. 5. The anvils 206 and 208 have arcuate configurations whichcorrespond to the arcuate configuration of the suture retainer 178. Ofcourse, the anvils 206 and 208 could have a different configuration ifdesired.

[0173] When the tissue securing system 174 is to be utilized to securethe body tissue 186, the suture 176 is positioned relative to the bodytissue in the manner illustrated schematically in FIG. 1. However, ifdesired, a separate anchor, similar to the anchor 120 of FIG. 4, couldbe connected with an end portion of each of the sections 182 and 184 ofthe suture 176. If this was done, the sections 182 and 184 of the suture176 could be separate from each other and interconnected by the bodytissue 176 and suture retainer 178. Thus, two separate segments ofsuture, that is the sections 182 and 184, would be interconnected by asingle suture retainer.

[0174] After the suture 176 has been positioned relative to the bodytissue, the upper (as viewed in FIG. 5) end portions of the sections 182and 184 of the suture 176 are inserted through the passages 190 and 192.The force distribution member 194 is positioned between the sutureretainer 178 and the body tissue 176. The sections 182 and 184 of thesuture are then tensioned with a predetermined force. The sutureretainer 178 is moved along the sections 182 and 184 of the suture 176into engagement with the force distribution member 194.

[0175] When the suture retainer 178 has been moved along the sections182 and 184 of the suture 176 into engagement with the forcedistribution member 194, a predetermined force is applied against sutureretainer 178, in the manner similar to that indicated schematically inFIG. 4, to press the force transmitting member 194 against the bodytissue 186 with a predetermined force. At the same time, the sections182 and 184 of the suture 176 are tensioned with a predetermined force.If the sections 182 and 184 are formed by a single piece of suture 176,in the manner illustrated schematically in FIG. 1, a connector sectionof the suture is pulled against the body tissue to compress the bodytissue between the suture retainer 178 and the connector section of thesuture. Alternatively, if separate suture anchors are connected with thesections 182 and 184 of the suture 176, the two spaced apart sutureanchors are pulled against the body tissue to compress the body tissue186 between the suture anchors and the suture retainer 178.

[0176] While the suture 176 is being tensioned with a predeterminedforce and while the suture retainer 178 is being pressed against theforce distribution member 194 with a predetermined force, the sutureretainer 178 is deformed to grip the sections 182 and 184 of the suture176. This deformation of the suture retainer 178 results in a firmgripping of the sections 182 and 184 of the suture 176 to maintain adesired tension force in the suture and to maintain a desiredcompression force against the body tissue 186.

[0177] To deform the suture retainer 178 to grip the suture 176, theanvils 206 and 208 are pressed against opposite sides of the sutureretainer with a predetermined force, as indicated schematically by thearrows 210 and 210 in FIG. 5. The horn 200 is then vibrated with anultrasonic frequency to transmit ultrasonic vibratory energy to thesuture retainer 178. It is contemplated that the horn 200 may bevibrated at a frequency of between 20 and 70 kilohertz. It is believedthat it may be preferred to vibrate the horn 200 at a frequency which isclose to or greater than 70 kilohertz.

[0178] Vibration of the horn 200 at ultrasonic frequencies transmitsmechanical vibrational energy form the horn 200 to the suture retainer178. This ultrasonic vibrational energy is converted into heat energyand results in a heating of the suture retainer 178. The heat in thesuture retainer tends to be concentrated in the material of the sutureretainer at locations adjacent to the passages 190 and 192. When thematerial of the suture retainer 178 adjacent to the passages 190 and 192has been heated into a transition temperature range for the material,the material of the suture retainer becomes soft and relatively pliable.However, the material of the suture retainer 178 does not melt andbecome liquid. The transmission of ultrasonic vibratory energy from thehorn 200 to the suture retainer 178 is then interrupted.

[0179] The anvils 206 and 208 continue to be pressed against the sutureretainer 178 with the forces indicated schematically by the arrows 210and 212 in FIG. 5. If desired, the force applied against the sutureretainer 178 may be increased upon interruption of the transmission ofultrasonic vibratory energy to the suture retainer. The force 210 and212 applied by the anvils 206 and 208 against the suture retainer 178 iseffective to plastically deform the heat softened material of the sutureretainer. The force applied by the anvils 206 and 208 collapses thepassages 190 and 192 and presses the softened material of the sutureretainer 178 against the sections 182 and 184 of the suture 176.

[0180] The suture retainer 178 and suture 176 may be formed of manydifferent materials. However, it is believed that it will be preferredto form the suture retainer 178 and the suture 176 of a biodegradablepolymer. The biodegradable polymer may advantageously be an amorphousthermoplastic. A bonding of the material of the suture retainer 178 withthe material of the suture 176 is promoted by forming the sutureretainer and suture of the same material. However, the suture retainer178 and suture 176 could be formed of different materials having similarchemical properties and which are compatible with each other.

[0181] In the embodiment of the invention illustrated in FIG. 5, thematerial of the suture retainer 178 is heated by the application ofultrasonic vibratory energy to the suture retainer by the horn 200.However, it is contemplated that heat energy could be directlytransmitted to the suture retainer 178 during the transmission ofultrasonic vibratory energy to the suture retainer if desired. To effectthe transmission of heat energy to the suture retainer 178, heatingelements could be provided in the anvils 206 and 208.

[0182] Referring to FIG. 29, another embodiment of the suture retainerillustrated in FIGS. 1-5 includes substantially flat edges 730, having anon-circular cross section when viewed from the top or the bottomsurface. The removal of material, which creates the non-circular shapecan help make the suture retainer better remain against smallersurfaces. In this regard, the top and/or bottom surface can include aconvex or concave surface.

[0183] Embodiment of FIG. 6

[0184] In the embodiment of the invention illustrated in FIGS. 1-5, thesuture retainer has a generally spherical configuration and is formed asone piece. In the embodiment of the invention illustrated in FIG. 6, thesuture retainer is formed as two pieces. Since the suture retainer ofFIG. 6 is similar to the suture retainers of FIGS. 1-5, similarterminology will be utilized to identify similar components. It shouldbe understood that one or more features of other embodiments of theinvention disclosed herein could be used with the embodiment of theinvention illustrated in FIG. 6.

[0185] A tissue securing system 218 (FIG. 6) is used in a sterile,operating room environment and includes a suture retainer 220 and suture228. The suture retainer 220 includes two sections, that is, a left (asviewed in FIG. 6) section 222 and a right section 224. The left andright sections 222 and 224 of the suture retainer 220 are formedseparately from each other. However, it is contemplated that the twosections 222 and 224 could be interconnected by a flexible connectorsection. The flexible connector section may be formed as one piece withthe left section 222 and the right section 224 of the suture retainer220.

[0186] A suture 228 includes sections 230 and 232 which are formedseparately from the sections 222 and 224 of the suture retainer 220. Thesuture 228 is positioned relative to human body tissue 234 with thesections 230 and 232 extending away from an outer side surface 236 ofthe body tissue. The suture 228 may be connected with the body tissue234 in the same manner as illustrated schematically in FIG. 1 ifdesired.

[0187] Although the suture 228 has been illustrated schematically inFIG. 6 in association with soft body tissue 234, it is contemplated thatthe suture could be associated with hard body tissue or with both hardand soft body tissue. It is also contemplated that the suture 228 couldextend through a suture anchor which is disposed in engagement with asurface of the body tissue or embedded in the body tissue.

[0188] The left section 222 of the suture retainer 220 has a generallyrectangular configuration. The left section 222 of the suture retainer220 includes a pair of parallel grooves 240 and 242. The grooves 240 and242 extend inward, that is, toward the left as viewed in FIG. 6, from aflat major side surface 244 of the left section 222 of the sutureretainer 220. The grooves 240 and 242 are each formed as a portion of acylinder.

[0189] Each of the grooves 240 and 242 has an extent which is slightlyless than one-half of the circumferential extent of a cylinder. Theradius of the grooves 240 and 242 is the same as the radius of thesuture sections 230 and 232. Since the grooves 240 and 242 have sidesurfaces which are formed as a portion of a cylinder and have an extentwhich is slightly less than one-half of the diameter of the cylinder,less than half of each of the suture sections 230 and 232 is disposed ina groove 240 and 242.

[0190] The right section 224 of the suture retainer 222 has aconfiguration which is the same as the configuration of the left section222. Thus, the right section 224 of the suture retainer 220 includes apair of grooves 248 and 250. The grooves 248 and 250 extend inward, thatis toward the right, as viewed in FIG. 6, from a flat major side surface252 of the right section 224 of the suture retainer 220.

[0191] The grooves 248 and 250 are each formed as a portion of acylinder. However, the grooves 248 and 250 have an extent which isslightly less than one-half the circumferential extent of the cylinder.The grooves 248 and 250 have a radius which is the same as the radius ofthe suture sections 230 and 232.

[0192] In one specific embodiment of the invention, the identical leftand right sections 222 and 224 had a rectangular configuration. Themajor side surfaces 244 and 252 had a length, as measured transverselyto the grooves 240, 242, 248 and 250, of approximately 0.236 inches. Themajor side surfaces 244 and 252 had a width, as measured parallel to thegroves 240, 242, 248 and 250, of approximately 0.119 inches. The leftand right sections 222 and 224 had a thickness, as measuredperpendicular to the major side surfaces 244 and 252, of approximately0.055 inches. The grooves 240, 242, 248, and 250 had a radius ofapproximately 0.046 inches. The depths of the grooves 240, 242, 248 and250 was approximately 0.005 inches less than the radius of the groovesor about 0.041 inches.

[0193] It should be understood that the foregoing dimensions for onespecific preferred embodiment of the suture retainer 222 have been setforth herein for purposes of clarity of description. It is contemplatedthat the sections 222 and 224 of the suture retainer 220 will beconstructed with dimensions which are substantially different from thespecific dimensions which have been set forth herein.

[0194] The two sections 222 and 224 of the suture retainer 220 may beformed of many different materials. However, it is believed that it willbe preferred to form the sections 222 and 224 of the suture retainer 220of a biodegradable polymer. The two sections 222 and 224 of the sutureretainer 220 may be formed of an amorphous thermoplastic material. Thesuture 228 and the suture retainer 220 may be formed of any of thematerials previously mentioned herein or other materials. The suture 228and the suture retainer 220 may be formed from the same material or fromdifferent materials having the same or similar chemical properties whichare compatible with each other.

[0195] When the suture 228 and suture retainer 220 are to be used tosecure the human body tissue 234, the suture 228 is positioned relativeto the body tissue. The suture 228 may be positioned relative to thebody tissue in the manner illustrated schematically in FIG. 1.Alternatively, the suture 228 may be connected with one or more sutureanchors. A predetermined tension force is then applied to the sections230 and 232 of the suture.

[0196] The two sections 222 and 224 of the suture retainer 220 arepositioned in engagement with the sections 230 and 232 of the suture228. The suture retainer 220 is pressed against the body tissue 234 witha predetermined force. This results in the body tissue being pressedbetween the suture retainer 220 and the portion of the suture connectedwith the body tissue 234. A force distribution member could be providedbetween the suture retainer 220 and body tissue 234 if desired.

[0197] The left section 222 of the suture retainer 220 is positioned inabutting engagement with the sections 230 and 232 of the suture 228 andwith the body tissue 234 in the manner illustrated schematically in FIG.6. The right section 224 of the suture retainer 220 is moved intoengagement with the sections 230 and 232 of the suture 228 and is alsopressed against the body tissue 234. At this time, the major sidesurface 252 on the right section 224 of the suture retainer 220 isspaced from and extends parallel to the major side surface 244 on theright section 222 of the suture retainer 220. The two sections 222 and224 of the suture retainer 220 are spaced apart by a distance which is afunction of the extent by which the diameters of the suture sections 230and 232 exceed the combined depth of the grooves 240 and 248 and thecombined depth of the grooves 242 and 250 in the sections 222 and 224 ofthe suture retainer 220.

[0198] In the specific example for which dimensions have been set forthherein, the major side surface 244 of the left section 222 of the sutureretainer 220 is spaced 0.010 inches from the major side surface 252 ofthe right section 224 of the suture retainer 220. It should beunderstood that a different spacing could be provided between the majorside surfaces 244 and 252 of the suture sections 222 and 224 when thegrooves 240 and 242 in the suture section 222 are in engagement with thesuture sections 230 and 232 and the grooves 248 and 250 in the rightsuture section 224 are in engagement with the suture sections 230 and232.

[0199] In order to bond the sections 222 and 224 of the suture retainer220 to each other and to the sections 230 and 232 of the suture 228,ultrasonic vibratory energy is transmitted to the suture retainer 220.At this time, the suture retainer 228 is pressed against the body tissue234 with a predetermined force and the sections 230 and 232 of thesuture 228 are tensioned with a predetermined force.

[0200] To effect the transmission of ultrasonic vibratory energy to thesections 222 and 224 of the suture retainer 220, an anvil 258 is movedinto engagement with the left section 222 of the suture retainer 220. Ahorn or acoustic tool 260 is moved into engagement with the rightsection 224 of the suture retainer 220. The anvil 258 and horn 260 arepressed against the sections 222 and 224 of the suture retainer 220 witha predetermined force to firmly press the sections of the sutureretainer against the sections 230 and 232 of the suture 228.

[0201] While the anvil 258 and horn 260 are being pressed against thesuture retainer sections 222 and 224 with a predetermined force,ultrasonic vibrations are transmitted from the horn 260 to the sutureretainer 220. The ultrasonic vibrations transmitted from the horn 260 tothe suture retainer 220 have a frequency in excess of 20 kilohertz. Theultrasonic vibrations transmitted to suture retainer 220 by the horn 260may have a frequency of between 20 kilohertz and 70 kilohertz. It isbelieved that it may be preferred to transmit ultrasonic vibrationshaving a frequency close to or greater than 70 kilohertz to the sutureretainer 220 from the horn 260.

[0202] The ultrasonic vibrations transmitted to the suture retainer 220create frictional heat and cause portions of the material of the sutureretainer 220 to be heated into the transition temperature range for thematerial. As the material of the suture retainer 220 is heated into itstransition temperature range, the material loses some of its rigidityand softens. The material of the suture retainer 220 does not melt andbecome liquid. The heat in the suture retainer 220 will tend to beconcentrated adjacent to the grooves 240, 242, 248 and 250 and adjacentto the major side surfaces 244 and 252.

[0203] As the material of the suture retainer 220 is heated and softenedby the ultrasonic vibratory energy, the sections 222 and 224 of thesuture retainer 220 are pressed together by force applied against thesections of the suture retainer by the anvil 258 and horn 260. As thisoccurs, the material of the sections 222 and 224 of the suture retainer220 is plastically deformed and pressed against the sections 230 and 232of the suture 228 at the grooves 240, 242, 248 and 250 in the sutureretainer. At the same time, at least portions of the major side surfaces248 and 252 on the sections 222 and 224 of the suture retainer 220 willmove into engagement with each other.

[0204] When this has occurred, the transmission of ultrasonic energy tothe suture retainer 228 is interrupted. However, the force appliedagainst the sections 222 and 224 is maintained. It is believed that itmay be desired to increase the force applied against the sections 222and 224 of the suture retainer 220 by the anvil 258 and horn 260 as theapplication of ultrasonic vibratory energy to the suture retainer 220 isinterrupted.

[0205] While the clamping force applied by the anvil 258 and horn 260 ismaintained, the left and right sections 222 and 224 of the sutureretainer 220 bond to each other. In addition, the left and rightsections 222 and 224 of the suture retainer 220 bond to the sections 230and 232 of the suture 228. This results in the suture 228 being firmlygripped by the sections of the suture retainer 220. The sections 222 and224 of the suture retainer 220 bond to the suture 228 withoutsignificant deformation of the suture.

[0206] The left and right sections 222 and 224 of the suture retainer220 bond to each other at a joint formed between the surfaces 244 and252 of the sections of the suture retainer. This results in a bonding ofthe sections 222 and 224 of the suture retainer 220 at locations offsetto both sides of the suture 228 and at locations offset to both sides ofthe suture 230. The material of the sections 222 and 224 of the sutureretainer 220 defining the grooves 240, 242, 248 and 250 bond to theouter side surfaces of the sections 230 and 232 of the suture 228.

[0207] Although it is preferred to heat the sections 222 and 224 of thesuture retainer 220 with ultrasonic vibratory energy in the mannerpreviously explained, it is contemplated that heat energy could bedirectly transmitted to the suture retainer if desired during thetransmission of ultrasonic vibratory energy to the suture retainer. Theheat energy could be transmitted to the suture retainer 220 from heatingcoils in the anvil 258 and/or horn 260. If desired, a separate heatapplication member could be provided.

[0208] The sections 222 and 224 of the suture retainer 220 preventdirect engagement of the anvil 258 and horn 260 with the suture 228.This prevents excessive heating of the suture 228.

[0209] Embodiment of FIGS. 7 and 8

[0210] In the embodiment of the invention illustrated in FIG. 6, thesuture retainer 220 is formed in two sections 222 and 224. In theembodiment of the invention illustrated in FIGS. 7 and 8, the sutureretainer is formed as one piece having passages for receiving thesections of the suture. Since the embodiment of the inventionillustrated in FIGS. 7 and 8 is generally similar to the embodiment ofthe invention illustrated in FIGS. 1-6, similar terminology will beutilized to identify similar components. It should be understood thatone or more of the features of the other embodiments of the inventionillustrated herein could be utilized in association with the embodimentof the invention illustrated in FIGS. 7 and 8.

[0211] A tissue securing system 268 is used in a sterile, operating roomenvironment and includes a suture retainer 270 and a suture 280. Thesuture retainer 270 is integrally formed as one piece and has acylindrical configuration. A pair of cylindrical passages 272 and 274(FIG. 7) extend diametrically through the suture retainer 270. Ofcourse, the suture retainer 270 and passages 272 and 274 could have adifferent configuration if desired. For example, the suture retainer 270could have an oval or a polygonal configuration.

[0212] Left and right sections 276 and 278 of a suture 280 extendthrough the passages 272 and 274. The suture sections 276 and 278 areconnected with layers of human body tissue (not shown) in the samemanner as has been illustrated schematically in FIG. 1. However, thesuture sections 276 and 278 could be connected with a suture anchorembedded in the body tissue. Alternatively, each of the sections 276 and278 of the suture 280 could be connected with a separate suture anchor,in much the same manner as in which the one section of the suture 112 ofFIG. 4 is connected with the suture anchor 120.

[0213] It is contemplated that the suture retainer 270 and suture 280could be used in association with hard body tissue, soft body tissue, orhard and soft body tissue. The suture retainer 270 and suture 280 may beused with body tissue in any one of the ways previously describedherein. Of course, the suture retainer and suture may be used with bodytissue in other known ways if desired.

[0214] The suture retainer 270 may be formed of many differentmaterials. However, It is believed that it will be preferred to form thesuture retainer 270 of a biodegradable polymer. It is believed that itmay be preferred to form both the suture retainer 270 and the suture 280of the same amorphous thermoplastic material. However, if desired, thesuture 280 and suture retainer 270 could be formed of differentmaterials which have the same or similar chemical properties and arecompatible with each other. The suture 280 and/or the suture retainer270 may be formed of either biodegradable or non-biodegradablematerials.

[0215] In one specific embodiment of the invention, the cylindricalsuture retainer 270 had a diameter of 0.119 inches. This particularsuture retainer 270 had an axial extent of 0.236 inches. The passages272 and 274 each had a diameter of 0.046 inches. If desired, thepassages 272 and 274 could be formed with an oval configuration withparallel flat surfaces having a length of 0.030 inches extending betweensemicircular opposite end portions of the ovals.

[0216] It should be understood that the foregoing specific dimensionsfor embodiments of the suture retainer 270 have been set forth hereinfor purposes of clarity of description. It is contemplated that thesuture retainer 270 can and will be formed with dimensions which aredifferent than these specific dimensions. It is also contemplated thatthe suture retainer 270 will be constructed with a configuration whichis different than the specific configuration illustrated herein. Forexample, the suture retainer 270 could have a prismatic configurationwith the passages 272 and 274 extending between one corner portion and aside surface of the prism.

[0217] The suture 280 is positioned relative to body tissue in much thesame manner as illustrated in FIG. 1. The sections 276 and 278 of thesuture 280 are then inserted through the passages 272 and 274 (FIG. 7).While the suture 280 is tensioned, the suture retainer 270 is movedalong the suture toward the body tissue. A predetermined force istransmitted from the suture retainer 270 to the body tissue while thesections 276 and 278 of the suture 280 are tensioned with apredetermined force in the manner previously described in conjunctionwith the embodiment of the invention illustrated in FIG. 4.

[0218] While the body tissue is compressed between the suture 280 andthe suture retainer 270, ultrasonic vibratory energy is transmitted tothe suture retainer 270. To transmit ultrasonic vibratory energy to thesuture retainer 270, an anvil 286 (FIG. 8) and a horn or acoustic tool288 are pressed against opposite sides of the suture retainer 270 with apredetermined force. The suture 280 is tensioned and the suture retainer270 is pressed against body tissue with predetermined forces while theanvil 286 and horn 288 are pressed against the suture retainer.

[0219] The horn 288 is then vibrated at an ultrasonic frequency, thatis, at a frequency greater than 20 kilohertz. The horn 280 may bevibrated at a frequency of between 20 and 70 kilohertz. It is believedthat it may be preferred to vibrate the horn 288 at a frequency close toor greater than 70 kilohertz. As this occurs, vibratory mechanicalenergy at ultrasonic frequencies is transmitted from the horn 288 to thesuture retainer 270.

[0220] The ultrasonic vibratory energy transmitted from the horn 288 tothe suture retainer 270 is effective to heat the suture retainer. Theheat tends to be concentrated in the portion of the suture retainer 270adjacent to the sections 276 and 278 of the suture 280.

[0221] When the portion of the suture retainer 270 adjacent to thesections 276 and 278 of the suture 280 have been heated to a temperaturein the transition temperature range for the material of the sutureretainer 270, the application of ultrasonic vibratory energy to thesuture retainer 270 by the horn 288 is interrupted. When material of thesuture retainer 270 is heated into the transition temperature range, thematerial of the suture retainer becomes soft and pliable. Although thematerial of the suture retainer 270 does not melt and become liquid, thematerial of the suture retainer 270 is softened and loses its rigiditywhen it is heated into the transition temperature range.

[0222] The force applied against the suture retainer 270 is thenmaintained or increased. The force applied against the suture retainer270 by the anvil 286 and horn 288 is effective to plastically deform thematerial of the suture retainer. As the heat softened material of thesuture retainer 270 is plastically deformed by the anvil 286 and horn288, the material of the suture retainer is firmly pressed against thesections 276 and 278 of the suture 280.

[0223] As the heated and softened material of the suture retainer 270cools, the material of the suture retainer bonds to the suture 280. Thisresults in the suture retainer 270 securely gripping the sections 276and 278 of the suture 280. The suture 280 is not significantly deformedas the suture retainer 270 is heated and bonded to the suture.Therefore, the strength of the suture 280 is not significantly reduced.

[0224] In the foregoing description, the suture retainer 270 was heatedby the application of ultrasonic vibratory energy to the sutureretainer. It is contemplated that heat energy could be transmitted tothe suture retainer 270 along with the ultrasonic vibratory energy. Thiscould be accomplished in many different ways. For example, a heatingelement could be provided in the anvil 286 and/or horn 288.Alternatively, a separate heating element could be moved into contactwith the suture retainer 270.

[0225] Embodiment of FIG. 9

[0226] In the embodiment of the invention illustrated in FIGS. 7 and 8,the suture 280 extends through passages 272 and 274 formed in the sutureretainer 270. In the embodiment of the invention illustrated in FIG. 9,the suture is wrapped around a section of the suture retainer and isengaged by other sections of the suture retainer. Since the sutureretainer of the embodiments of the invention illustrated in FIGS. 1-8 issimilar to the suture retainer of the embodiment of the inventionillustrated in FIG. 9, similar terminology will be utilized to identifysimilar components. It should be understood that one or more features ofother embodiments of the invention disclosed herein may be used with theembodiment of the invention illustrated in FIG. 9.

[0227] A tissue securing system 291 is used in a sterile, operating roomenvironment and includes a suture retainer 292 and a suture 302. Thesuture retainer 292 includes a cylindrical central section 294 which isdisposed between left and right side sections 296 and 298. The centralsection 294 is formed separately from the side sections 296 and 298. Theside sections 296 and 298 are formed separately from each other.However, the side sections 296 and 298 could be interconnected ifdesired. For example, the side sections 296 and 298 could be integrallyformed as one piece with a flexible connector section which extendsbetween the side sections. Alternatively, the central section 294 andside sections 296 and 298 could be formed as one piece.

[0228] A suture 302 is wrapped around the central section 294. Thesuture 302 is received in a groove 304 in the central section 294. Thegroove 304 has a circular configuration and has a central axis which iscoincident with a central axis of the cylindrical central section 294.

[0229] The groove 304 has an extent which is greater than 360° andextends completely around the central section 294 of the suture retainer292. The groove 304 is formed as a portion of a helix. Opposite endportions of the groove 304 are disposed in an overlapping relationshipon the central portion 294 of the suture retainer 292. The suture 302 isdisposed in the groove 304 throughout the extent of its engagement withthe central section 294.

[0230] Although the groove 304 has been shown as having somewhat morethan a single turn in FIG. 8, the groove could have a plurality of turnsaround the central section 294 of the suture retainer 292 if desired. Ifthis was done, the suture 302 would be wrapped a plurality of timesaround the central section 294. Thus, rather than having a single wrapof the suture 302 around the central section 294 of the suture retainer292 in the manner illustrated in FIG. 9, the suture 302 could be wrappeda plurality of times around the central section of the suture retainer294.

[0231] The suture 302 and suture retainer 292 may be formed of the samematerial or different materials. Similarly, the central section 294 andside sections 296 and 298 may be formed of the same material ordifferent materials. It is believed that it may be preferred to form thesuture 302 and the suture retainer 294 from biodegradable materials.However, the suture 302 and/or the suture retainer 292 could be formedof materials which are not biodegradable. It may also be preferred toform the suture retainer 292 and suture 302 of an amorphous polymericmaterial. The suture retainer 292 and suture 302 may be formed of any ofthe materials previously mentioned herein or other materials.

[0232] When the suture retainer 292 is to be utilized to secure humanbody tissue, the suture 302 is positioned relative to the body tissue inthe manner illustrated in FIG. 4. Of course, the suture 302 could bepositioned relative to body tissue in a different manner if desired. Thesuture 302 and suture retainer 292 may be used with hard, soft, or hardand soft body tissue.

[0233] The suture 302 is wrapped around the central section 294 of thesuture retainer, in the manner illustrated schematically in FIG. 9. Oncethe suture 302 has been wrapped around the central section 294 of thesuture retainer 292, the central section of the suture retainer is movedalong the suture 302 toward the body tissue.

[0234] As the central section 294 of the suture retainer 292 movestoward the body tissue, a wrap or turn of the suture 302 around thecentral section of the suture retainer moves along the suture toward thebody tissue. The central section 294 of the suture retainer 292 may bemoved along a straight path toward the body tissue without rotatingwhile tension is maintained in the suture 302 and the suture slidesalong the groove 304 in the central section of the suture retainer.Alternatively, the central section 294 of the suture retainer could berolled along the suture 302 toward the body tissue.

[0235] The central section 294 of the suture retainer 292 is moved alongthe suture 302 until the central section of the suture retainer engagesthe body tissue in the manner illustrated in FIG. 4 or engages a forcedistribution member in the manner illustrated in FIG. 5. A predeterminedtension force is then applied to the suture 302 and the central section294 of the suture retainer is urged toward the body tissue with apredetermined force. The body tissue engaged by the suture 302 iscompressed between the central section 294 of the suture retainer 292and a suture anchor, similar to the suture anchor 120 of FIG. 4.

[0236] While the suture 302 is tensioned with a predetermined force anda predetermined force is transmitted from the central section 294 of thesuture retainer 292 to the body tissue, the side sections 296 and 298are aligned with the central section 294 of the suture retainer. Theside sections 296 and 298 have concave surfaces 310 and 312 which arepressed against the turn in the suture 302 which extends around thecentral portion 294 of the suture retainer 292. The surfaces 310 and 312have an arc of curvature which is the same as the arc of curvature of agenerally cylindrical outer side surface 314 on the side sections 296and 298. However, since the suture 302 projects out of the groove 304,the side surfaces 310 and 312 on the side sections 296 and 298 areslightly spaced from the side surface 314 on the central section 294 ofthe suture retainer 292.

[0237] In accordance with a feature of the present invention, ultrasonicvibratory energy is applied to the suture retainer 292. To apply theultrasonic vibratory energy to the suture retainer 292, a support memberor anvil 320 is pressed against the side section 296 of the sutureretainer 292. A horn or acoustic tool 322 is pressed against the sidesection 298 of the suture retainer 292. The anvil 320 and horn 322 arepressed against the opposite side sections 296 and 298 of the sutureretainer 292 with a predetermined force.

[0238] While the suture retainer 292 is clamped between the anvil 320and horn 322, mechanical vibrations at an ultrasonic frequency aretransmitted from the horn 322 to the suture retainer 292. The ultrasonicvibratory energy is transmitted from the horn 322 to the suture retainer292 at frequency above 20 kilohertz. The horn 322 may transmit theultrasonic vibratory energy to the suture retainer 292 at a frequencybetween 20 kilohertz and 70 kilohertz. It is contemplated that it may bedesired to have the ultrasonic vibratory energy transmitted to thesuture retainer at a frequency close to or greater than 70 kilohertz.However, it should be understood that the ultrasonic vibratory energycould be transmitted to the suture retainer 292 at any desired frequencyabove the frequency normally detected by the human ear, that is aboveapproximately 20 kilohertz.

[0239] The ultrasonic vibratory energy transmitted to the sutureretainer 292 is converted into heat. The heat tends to concentrate atthe joints between the side sections 296 and 298 and central section 294of the suture retainer 292. This results in the material forming theside sections 296 and 298 and the central section 294 of the sutureretainer 292 being heated into the transition temperature range of thematerial forming the suture retainer. The application of the ultrasonicvibratory energy to the suture retainer 292 by the horn 322 is theninterrupted.

[0240] As the material of the suture retainer 292 is heated into itstransition temperature range, the material loses its rigidity andsoftens. The anvil 320 and horn 322 apply force against the sutureretainer 292 to plastically deform the material of the suture retainer.The softened side surfaces 310 and 312 on the side sections 296 and 298are pressed against and are indented by the suture 302. As this occurs,the softened side surfaces 310 and 312 of the side sections 296 and 298move into engagement with the softened side surface 314 on the centralsection 294 of the suture retainer 292.

[0241] Although the application of ultrasonic vibratory energy to thesuture retainer 292 is interrupted, the anvil 320 and horn 322 continueto be pressed against the side sections 296 and 298 of the sutureretainer 292 with a predetermined force. If desired, the force withwhich the anvil 320 and horn 322 are pressed against the suture retainer292 can be increased as the transmission of ultrasonic vibratory energyto the suture retainer is interrupted.

[0242] As the material of the suture retainer 292 cools, the sidesections 296 and 298 are bonded to the central section 294 of the sutureretainer 292. In addition, the suture 302 is bonded to the centralsection 294 and to the side sections 296 and 298 of the suture retainer292.

[0243] The groove 304 in the central section 294 of the suture retainer292 is deep enough to prevent significant deformation and loss ofstrength of the suture 302. As the heat softened material of the sidesections 296 and 298 of the suture retainer is pressed against thesuture 302, the material of the side sections is plastically deformed.

[0244] It is contemplated that a of the suture 302 with the centralsection 294 and side sections 296 and 298 of the suture retainer 292 maybe promoted by forming the suture and the sections of the sutureretainer of the same material. The material may be an amorphousthermoplastic which is biodegradable.

[0245] If desired, the groove 304 could be omitted from the centralsection 294 of the suture retainer 292. Alternatively, the groove 304could be deepened so that the groove has a depth which is equal to orslightly greater than the diameter of the suture 302. If desired, thegroove 304 could be formed with an undercut configuration so that theportion of the suture 302 in the groove 304 is not exposed to the sidesections 296 and 298 of the suture retainer 292. If this was done, thesuture 302 would be bonded to only the central section 294 of the sutureretainer 292 and would not be bonded to the side sections 296 and 298 ofthe suture retainer.

[0246] If the configuration of groove 304 is changed to an undercutconfiguration, the suture 302 would be completely enclosed by thegroove. A groove having this configuration is disclosed in U.S. Pat. No.6,010,525 which has been and hereby is incorporated herein in itsentirety. If the groove 304 has such an undercut configuration, the sidesections 296 and 298 could be eliminated. The anvil 320 and horn 322would then be pressed against opposite sides of the cylindrical outerside surface 314 of the central section 294 in the same manner as isdisclosed in FIG. 8 in association with the suture retainer 270. As isdisclosed in the aforementioned U.S. Pat. No. 6,010,525, the groove andsuture could extend for a plurality of turns around the central portion294 of the suture retainer 292.

[0247] In the foregoing description, it has been assumed that onlyultrasonic vibrational energy may be transmitted to the suture retainer292 to effect a securing of the suture 302 by the suture retainer 292.However, thermal energy in the form of heat could be directly applied tothe suture retainer 292 if desired. This could be accomplished in manydifferent ways. For example, a heating element could be provided in theanvil 320 and/or the horn 322.

[0248] Embodiment of FIGS. 10 and 11

[0249] In the embodiment of the invention illustrated in FIG. 9, thesuture 302 is wrapped around a central section 294 of the sutureretainer 292. In the embodiment of the invention illustrated in FIGS. 10and 11, sections of the suture extend through passages in a centralsection of the suture retainer. Since the embodiment of the inventionillustrated in FIGS. 10 and 11 is generally similar to the embodimentsof the invention illustrated in FIGS. 1-9, similar terminology will beutilized to identify similar components. It should be understood thatone or more of the features of the other embodiments of the inventiondisclosed herein could be used with the embodiment of the inventionillustrated in FIGS. 10 and 11 if desired.

[0250] A tissue securing system 328 is used in a sterile, operating roomenvironment and includes a suture 330 and suture retainer 340. Thesuture 330 (FIGS. 10 and 11) has a pair of sections 332 and 334 whichare connected with human body tissue. The sections 332 and 334 of thesuture 330 may connected with body tissue in the manner illustratedschematically in FIG. 1. The sections 332 and 334 of the suture 330extend through a central section 338 of the suture retainer 340 (FIG.11). In addition to the central section 338, the suture retainer 340includes a pair of side sections 342 and 344.

[0251] The central section 338 and side sections 342 and 344 all haverectangular configurations. However, the central and side sections 338,342 and 344 (FIG. 11) could have a different configuration if desired.The central section 338 is thinner (as viewed in FIG. 11) than the sidesections 342 and 344. The sections 332 and 334 of the suture 330 extendthrough cylindrical passages 348 and 350 in the central section 338.

[0252] The relatively thin central section 338 and the relatively thickside sections 342 and 344 of the suture retainer 340 are formed of abiodegradable material. The suture 330 is also formed of a biodegradablematerial. The suture 330 and suture retainer 340 may be formed of thesame biodegradable material. It may be preferred to form the suture 330and suture retainer 340 of an amorphous polymer. If desired, the suture330 and suture retainer 340 could be formed of different materials whichare compatible and have the same or similar chemical properties. Thesuture 330 and suture retainer 340 may be formed of any of the materialspreviously mentioned herein or of other known materials.

[0253] When the suture 330 and suture retainer 340 are to be used tosecure human body tissue, the sections 332 and 334 of the suture 330 arepositioned relative to body tissue in a manner similar to that disclosedin FIG. 1. The sections 332 and 334 of the suture 330 are then insertedthrough the passages 348 and 350 in the central section 338 of thesuture retainer 340. While the suture 330 is tensioned, the centralsection 338 of the suture retainer 340 is moved along the suture towardthe body tissue.

[0254] The central section 338 of the suture retainer 340 is pressedagainst either the body tissue in the manner illustrated schematicallyin FIG. 4 or against a force distribution member in the mannerillustrated schematically in FIG. 5. While a predetermined force istransmitted from the central section 338 of the suture retainer 340 tothe body tissue and while the sections 332 and 334 of the suture 330 aretensioned with a predetermined force, the thick side sections 342 and344 of the suture retainer 340 are positioned in engagement withopposite sides of the thin central section 338, in the mannerillustrated in FIG. 11.

[0255] An apparatus for transmitting ultrasonic vibratory energy to thesuture retainer 340 is then moved into engagement with the side sections342 and 344 of the suture retainer. The apparatus for applyingultrasonic vibratory energy to the suture retainer 340 includes an anvilor support portion 354 and a horn or acoustic tool 356. The anvil 354and horn 356 are pressed against opposite sides of the suture retainerwith a predetermined force. While the suture retainer 340 is clampedbetween the anvil 354 and horn 356, ultrasonic vibratory energy istransmitted from the horn 356 to the suture retainer 340.

[0256] The ultrasonic vibratory energy transmitted from the horn 356 tothe suture retainer 340 is effective to heat the material of the sutureretainer. The heat tends to be concentrated at the joints between thethick side sections 342 and 344 and the thin central section 338 of thesuture retainer 340. In addition, the heat tends to be concentrated atthe joint between the sections 332 and 334 of the suture and the centralsection 338 of the suture retainer. This results in a substantialportion of the material of the thin central section 338 of the sutureretainer 340 being heated into its transition temperature range.

[0257] As the material of the suture retainer 340 is heated into itstransition temperature range, the material of the suture retainer losesits rigidity and becomes soft. However, the material of the sutureretainer is not heated enough to melt the material of the sutureretainer. Since the central section 338 is relatively thin, the materialof the central section becomes very pliable while the side sections 342and 344 still have some rigidity.

[0258] Once a substantial portion of the material of the central section338 of the suture retainer 340 has been softened by being heated intoits transition temperature range, the transmission of ultrasonicvibratory energy from the horn 356 to the suture retainer 340 isinterrupted. However, the anvil 354 and horn 356 continue to apply forceagainst opposite sides of the suture retainer 340. The magnitude of theforce applied against opposite sides of the suture retainer 340 by theanvil 354 and horn 356 may be increased as the transmission ofultrasonic vibratory energy from the horn 356 to the suture retainer 340is interrupted. The force applied against opposite sides of the sutureretainer 340 by the anvil 354 and horn 356 is effective to plasticallydeform the heat softened material of the suture retainer 340.

[0259] As the suture retainer 340 cools, the side sections 342 and 344of the suture retainer are bonded to the central section 338 of thesuture retainer. In addition, the central section 338 of the sutureretainer 340 is bonded to the sections 332 and 334 of the suture 330.This results in the suture 330 being securely gripped by the sutureretainer 340. However, there is no significant deformation of the suture330 so that the strength of the suture 330 is not significantly reduced.

[0260] In the foregoing description, the material of the central section338 of the suture retainer 340 was heated by the transmission ofultrasonic vibratory energy to the suture retainer 340. However, it iscontemplated that thermal energy could be applied to the suture retainer340 along with the ultrasonic vibratory energy. This could beaccomplished by providing a heating element in the anvil 354 and/or horn356. Alternatively, a separate member could be utilized to apply heatdirectly to the suture retainer 340.

[0261] The anvil 354 and horn 356 engage only the suture retainer 340.The anvil 354 and horn 356 are maintained in a spaced apart relationshipwith the suture 330. This prevents excessive heating and/or deformationof the suture. Embodiment of FIGS. 12 and 13

[0262] In the embodiment of the invention illustrated in FIGS. 10 and11, the sections of the suture extend through passages in a centralsection of the suture retainer. In the embodiment of the inventionillustrated in FIGS. 12 and 13, the sections of the suture are disposedin grooves formed in the central section of the suture retainer. Sincethe embodiment of the invention illustrated in FIGS. 12 and 13 isgenerally similar to the embodiments of the invention illustrated inFIGS. 1-11, similar terminology will be utilized to designate similarcomponents. It should be understood that one or more of the features ofother embodiments of the invention disclosed herein could be used withthe embodiment of the invention illustrated in FIGS. 12 and 13.

[0263] A tissue securing system 359 (FIGS. 12 and 13) is used in asterile, operating room environment and includes a suture 360 and asuture retainer 368. The suture 360 has left and right sections 362 and364. The sections 362 and 364 of the suture 360 are connected with humanbody tissue in a manner similar to the manner illustrated schematicallyin FIG. 1. However, the sections 362 and 364 of the suture 360 could beconnected with body tissue in a different manner if desired. Forexample, the sections 362 and 364 could be connected with a sutureanchor embedded in the body tissue. Alternatively, a separate sutureanchor could be provided for each of the sections 362 and 364 of thesuture 360.

[0264] A suture retainer 368 includes a central section 370. A pair ofside sections 372 and 374 are disposed on opposite sides of the centralsection 370. The central section 370 and side sections 374 all have agenerally rectangular configuration. However, the central section 370 isthinner than the side sections 372 and 374 (FIG. 13).

[0265] A pair of grooves 378 and 380 are provided in the central section370. The grooves 378 and 380 have parallel longitudinal central axes.The grooves 378 and 380 are disposed in opposite sides of the centralsection 370 and open in opposite directions.

[0266] In addition, a groove 384 is formed in the side section 372. Thegroove 384 extends parallel to and is aligned with the groove 380 in thecentral section 370. Similarly, a groove 386 is formed in the sidesection 374. The groove 386 extends parallel to and is aligned with thegroove 378 in the central section 370. The section 362 of the suture 360is received in the grooves 378 and 386 (FIG. 13). Similarly, the section364 of the suture 360 is received in the grooves 380 and 384.

[0267] The grooves 378 and 386 are aligned with each other and areoffset to one side of the grooves 380 and 384. This results in thesections 362 and 364 of the suture 360 being offset from each other(FIG. 13). However, if desired, the grooves 378 and 386 and the grooves380 and 384 could all be aligned. This would result in the sections 362and 364 of the suture being aligned with each other.

[0268] The central section 370 and side sections 372 and 374 of thesuture retainer 368 are formed of a biodegradable material. The suture360 is also formed of a biodegradable material. The suture 360 andsuture retainer 368 may be formed of the same biodegradable material. Itmay be preferred to form the suture 360 and suture retainer 368 of anamorphous polymer. If desired, the suture 360 and suture retainer 368could be formed of different materials which are compatible and have thesame or similar chemical properties. It is contemplated that the suture360 and suture retainer 368 could be formed of any of the materialspreviously mentioned herein or of other materials.

[0269] The suture 360 is positioned relative to body tissue in the samemanner as is illustrated schematically in FIG. 1. While the sections 362and 364 of the suture are tensioned with a predetermined force, thecentral section 370 of the suture retainer 368 is positioned relative tothe sections 362 and 364 of the suture 360. In addition, the sidesections 372 and 374 are positioned relative to the sections 362 and 364of the suture and relative to the central section 370. The centralsection 370 and side sections 372 and 374 of the suture retainer 368 areurged toward the body tissue in the manner illustrated schematically inFIG. 4. This results in the transmission of a predetermined force fromthe suture retainer 360 to the body tissue while the sections 362 and364 of the suture 360 are tensioned with a predetermined force.

[0270] In accordance with one of the features of the present invention,ultrasonic vibratory energy is then transmitted to the suture retainer368. To transmit ultrasonic vibratory energy to the suture retainer 368,an anvil or support member 390 (FIG. 13) is pressed against the sidesection 372 of the suture retainer 368. In addition, a horn or acoustictool 392 is pressed against the side section 374 of the suture retainer368. While the suture retainer 368 is clamped between the anvil 390 andhorn 392, ultrasonic vibratory energy is transmitted from the horn tothe suture retainer.

[0271] The ultrasonic vibratory energy transmitted from the horn 392 tothe suture retainer 368 may have a frequency in a range between 20kilohertz and 70 kilohertz. It is believed that it will be preferred totransmit ultrasonic vibratory energy having a frequency of approximately70 kilohertz or more from the horn 392 to the suture retainer 368.

[0272] The ultrasonic vibratory energy is effective to heat the sutureretainer 368. The heat is concentrated at the joints between the thincentral section 370 and thick side sections 372 and 374 of the sutureretainer 368. Since the central section 370 is thinner than the sidesections 372 and 374, a substantial percentage of the material of thecentral section 370 is heated into its transition temperature rangewhile a smaller percentage of the material of the side sections 372 and374 is heated into its transition temperature range.

[0273] Heating the material of the suture retainer 368 into thetransition temperature range is effective to cause the material of thesuture retainer to soften and lose its rigidity. Although the materialof the suture retainer 368 softens, the material does not melt andbecome liquid. The softened material of the suture retainer is pliableand plastically deforms under the influence of the clamping forceapplied by the anvil 390 and horn 392.

[0274] As the material of the suture retainer 368 plastically deforms, aflat major side surface 396 on the central section 370 of the sutureretainer 368 and a flat side surface 398 on the side section 372 of thesuture retainer move into engagement. At the same time, a flat sidesurface 402 on the central section 370 of the suture retainer 368 and aflat side surface 404 on the side section 374 of the suture retainermove into engagement. As this occurs, the softened material of thecentral section 370 of the suture retainer 368 is deformed by forceapplied to the central section through the sections 362 and 364 of thesuture 360.

[0275] After material of the suture retainer 368 has been heated intoits transition temperature range, the application of ultrasonicvibratory energy to the suture retainer is interrupted. However, theforce pressing the anvil 390 and the horn 392 against the sutureretainer is maintained. If desired, the magnitude of the force appliedagainst the suture retainer 368 by the anvil 390 and horn 392 may beincreased simultaneously with the interruption of the application ofultrasonic vibratory energy to the suture retainer.

[0276] As the material of the suture retainer 368 cools, the flat majorside surface 396 on the central section 370 bonds to the flat major sidesurface 398 on the side section 372. In addition, the flat major sidesurface 402 on the central section 370 bonds to the flat major sidesurface 404 on the side section 374. The surfaces defining the grooves378 and 380 in the central section 370 of the suture retainer 368 bondto the sections 362 and 364 of the suture 360. The surfaces defining thegrooves 384 and 386 in the side sections 372 and 374 of the sutureretainer 368 also bond to the sections 362 and 364 of the suture 360.

[0277] In the foregoing description, the suture retainer 368 was heatedby the application of ultrasonic vibratory energy to the sutureretainer. It is contemplated that the suture retainer 368 could also beheated by the direct application of thermal energy to the sutureretainer. If this is to be done, a heating element could be provided inthe anvil 390 and/or horn 392. If desired, a separate heating elementcould be moved into engagement with the suture retainer to transmit heatto the suture retainer.

[0278] The anvil 390 and horn 392 engage only the suture retainer 368.The anvil 390 and horn 392 are maintained in a spaced apart relationshipwith the suture 360. This prevents excessive heating and/or deformationof the suture 360.

[0279] Embodiment of FIGS. 14 and 15

[0280] In the embodiment of the invention illustrated in FIGS. 12 and13, straight sections 362 and 364 of the suture 360 are connected withthe suture retainer 368. In the embodiment of the invention illustratedin FIGS. 14 and 15, sections of the suture are wrapped around a portionof the suture retainer. Since the embodiment of the inventionillustrated in FIGS. 14 and 15 is generally similar to the embodimentsof the invention illustrated in FIGS. 1-13, similar terminology will beutilized to describe similar components. It should be understood thatone or more of the features of other embodiments of the invention couldbe utilized in association with the embodiment of the inventionillustrated in FIGS. 14 and 15 if desired.

[0281] A tissue securing system 408 (FIG. 15) is used in a sterile,operating room environment and includes a suture 410 and a sutureretainer 418. The suture 410 includes left and right sections 412 and414. The left and right sections 412 and 414 of the suture 410 areconnected with human body tissue in the manner illustrated schematicallyin FIG. 1. Alternatively, the left and right sections 412 and 414 of thesuture 410 could be connected with a single suture anchor. If desired, asuture anchor could be provided in association with each of the sections412 and 414 of the suture 410.

[0282] The suture retainer 418 (FIG. 15) includes a central section 420and a pair of side sections 422 and 424. The central section 420 andside sections 422 and 424 of the suture retainer 418 are formed of abiodegradable material. The suture 410 is also formed of a biodegradablematerial. The suture 410 and suture retainer 418 may be formed of thesame biodegradable material. It may be preferred to form the suture 410and suture retainer 418 of an amorphous polymer. If desired, the suture410 and suture retainer 418 could be formed of different materialshaving the same or substantially similar chemical properties. The suture410 and suture retainer 418 could be formed of any of the materialspreviously mentioned herein or other materials.

[0283] When the suture retainer 418 is to be utilized to secure bodytissue, the suture sections 412 and 414 are wrapped around the centralsection 420 of the suture retainer in the manner illustratedschematically in FIG. 14. While the sections 412 and 414 of the suture410 are tensioned, the central section 420 of the suture retainer ismoved along the suture 410 toward the body tissue. Of course, the turnsor wraps formed around the central section 420 of the suture retainer418 are moved toward the body tissue along with the central section.

[0284] The central section 420 of the suture retainer is moved intoengagement with the body tissue or with a force distribution member inthe manner similar to that illustrated in either FIG. 4 or FIG. 5. Whilea predetermined force is transmitted from the central section 420 of thesuture retainer to the body tissue, the sections 412 and 414 of thesuture 410 are tensioned with a predetermined force. This results in thebody tissue being compressed under the influence of force beingtransmitted to the body tissue from the central section 420 of thesuture retainer 418 and from the suture 410.

[0285] While the suture is being tensioned with a predetermined forceand while the predetermined force is being transmitted from the centralsection 420 of the suture retainer 418, the side sections 422 and 424are moved into juxtaposition with the central section 420 of the sutureretainer 418. The side sections 422 and 424 are thicker than the centralsection 420. Force is also transmitted from the side sections 422 and424 to the body tissue.

[0286] To effect the application of ultrasonic vibratory energy to thesuture retainer 418, and anvil or support portion 428 is pressed againstthe relatively thick side section 422 of the suture retainer 418. At thesame time, a horn or acoustic tool 430 is pressed against the relativelythick side section 424 of the suture retainer 418. This results in thesuture retainer 418 being clamped between the anvil 428 and horn 430with a predetermined force. The clamping force presses the suture 410against the relatively thin central section 420 of the suture retainer.

[0287] While maintaining the predetermined clamping force on the sutureretainer 418, ultrasonic vibratory energy is transmitted from the horn430 to the suture retainer. The ultrasonic vibratory energy istransmitted at a frequency of between 20 kilohertz and 70 kilohertz. Itis believed that it may be preferred to transmit the ultrasonicvibratory energy at a frequency close to or greater than 70 kilohertz.

[0288] The ultrasonic vibratory energy is effective to heat the sutureretainer 418. The heat tends to be concentrated at the joints betweenthe thin central section 420 and thick side sections 422 and 424 of thesuture retainer 418. Since the central section 420 of the sutureretainer 418 is thinner than the side sections 422 and 424 of the sutureretainer, a larger percentage of the material of the central section 420of the suture retainer 418 is heated into its transition temperaturerange by the ultrasonic vibratory energy before a correspondingpercentage of the side sections 422 and 424 is heated into thetransition temperature range.

[0289] When the material of the suture retainer 418 has been heated intoits transition temperature range, the material becomes soft and pliable.The clamping force applied against the side sections 422 and 424 causesthe turns in the sections 412 and 414 of the suture 410 to indent andplastically deform the heat softened material of the central section 420and side sections 422 and 424. As this occurs, the side sections 422 and424 move into abutting engagement with the central section 410 under theinfluence of the clamping force applied by the anvil 428 and horn 430.

[0290] Once the material of the central section 420 and side sections422 and 424 adjacent to the turns in the sections 412 and 414 of thesuture 410 have been heated into the transition temperature range, theapplication of ultrasonic vibratory energy to the suture retainer 418 isinterrupted. However, the clamping force applied against the sutureretainer by the anvil 428 and horn 430 is maintained constant orincreased as the application of ultrasonic vibratory energy to thesuture retainer is interrupted. As the material of the suture retainer418 cools, while the suture retainer is clamped between the anvil 428and horn 430, the side sections 422 and 424 of the suture retainer 418bond to the central section 420 of the suture retainer. In addition, theside sections 422 and 424 and the central section 420 of the sutureretainer 418 bond to the suture 410.

[0291] Embodiment of FIGS. 16 and 17

[0292] In the embodiments of the invention illustrated in FIGS. 9through 15, the suture retainer is formed by a plurality of sectionswhich are bonded together. In the embodiment of the inventionillustrated in FIGS. 16 and 17, the suture retainer is formed as onepiece. Since the suture retainer in the embodiment of FIGS. 16 and 17 isgenerally similar to the suture retainers of FIGS. 1-16, similarterminology will be utilized to identify similar components. It shouldbe understood that one or more of the features of any of the otherembodiments of the invention disclosed herein could be utilized with theembodiment of the invention illustrated in FIGS. 16 and 17.

[0293] A tissue securing system 438 is used in a sterile, operating roomenvironment and includes a suture 440 and a suture retainer 448. Thesuture 440 includes left and right sections 442 and 444. The left andright sections 442 and 444 of the suture 440 are connected with humanbody tissue in a manner similar to the manner illustrated schematicallyin FIG. 1. However, the suture 440 could be connected with body tissuein a different manner if desired. For example, the sections 442 and 444could be connected with a single suture anchor embedded in body tissue.Alternatively, a separate suture anchor could be provided for each ofthe sections 442 and 444 if desired.

[0294] A one-piece suture retainer 448 is formed separately from thesuture 440. The suture retainer 448 has a generally H-shapedconfiguration. The suture retainer 448 includes a rectangular basesection 450 and a pair of arm sections 452 and 454. The arm sections 452and 454 are connected with the base section 450 by a connector section456. Although only the one side, which may be considered as the top sideof the suture retainer 448 is illustrated in FIG. 16, the sutureretainer has a generally rectangular configuration. The extent of thesuture retainer 448 along the sections 442 and 444 of the suture 440 maybe equal to the distance between longitudinal central axes of thesections of the suture.

[0295] The suture retainer 448 has a pair of recesses 460 and 462 inwhich the sections 442 and 444 of the suture 440 are received. Anentrance 466 to the recess 460 (FIG. 17) is partially blocked by a noseor detent portion 468 of the arm section 452. When the suture section442 is to be moved into the recess 460, the cylindrical outer sidesurface of the suture section 442 is pressed against a cam surface 472on the nose portion 468 of the arm section 452. Force applied againstthe cam surface 472 resiliently deflects the arm section 452 away fromthe base section 450 from the position shown in solid lines in FIG. 17to the position shown in dashed lines. As this occurs, the section 442of the suture 440 moves into the recess 460. As the section 442 of thesuture 440 moves into the recess 460, the arm section 452 springs backto the initial position shown in solid lines in FIG. 17 to block theentrance 446 to the recess 460. This results in the suture section 442being retained in the recess 460.

[0296] The arm section 454 has the same construction as the arm section452. Thus, the arm section 454 has a nose or detent portion 476 (FIG.16) which is engaged by the suture section 444 to deflect the armsection 454 as the suture section moves into the recess 462. Once thesuture section 444 has moved into the recess 462, the nose portion 476on the arm section 454 blocks the entrance to the recess to retain thesuture section 444 in the recess.

[0297] The suture 440 and suture retainer 448 are both formed of abiodegradable polymer. It is believed that it may be preferred to formthe suture retainer 448 and suture 440 from an amorphous thermoplastic.The suture 440 and suture retainer 448 may be formed of the samematerial or different materials having similar chemical properties whichare compatible. The suture 440 and suture retainer 448 may be formed ofany of the materials previously mentioned herein or of other materials.

[0298] When the suture 440 and suture retainer 448 are to be utilized tosecure human body tissue, the suture 440 is positioned relative to thebody tissue, in a manner similar to that illustrated schematically inFIG. 1. The sections 442 and 444 of the suture 440 are then moved intothe recesses 460 and 462 in the suture retainer 448. The nose portions468 and 476 on the arm sections 452 and 454 are effective to retain thesuture sections 442 and 444 in the recesses 460 and 462.

[0299] While the suture sections 442 and 444 are tensioned, the sutureretainer 448 is moved along the suture 440 toward the body tissue. Thenose portions 468 and 476 on the arm sections 452 and 454 maintain thesuture sections 442 and 444 in the recesses 460 and 462 as the sutureretainer 448 is moved along the suture 440 toward the body tissue. Thesuture retainer 448 is moved into engagement with either the bodytissue, in the manner similar to that illustrated in FIG. 4, or intoengagement with a force distribution member, in the manner similar tothat illustrated in FIG. 5.

[0300] While a predetermined tension force is applied to the sections442 and 444 of the suture 440 and while the suture retainer 448 is urgedtoward the body tissue with a predetermined force, the suture retainer448 is bonded to the suture 440. This results in a predetermined tensionbeing maintained in the portion of the suture 440 connected with thebody tissue and in the transmission of a predetermined force from thesuture retainer 448 to the body tissue.

[0301] To bond the suture 440 to the suture retainer 448, an anvil orsupport portion 480 is pressed against the base section 450 of thesuture retainer 448. A horn or acoustic tool 482 is pressed against thearm sections 452 and 454 of the suture retainer 448. The arm sections452 and 454 of the suture retainer 448 have protuberances 486 and 488which extend toward the horn 482.

[0302] The suture retainer 448 is clamped between the anvil 480 and horn482. The force applied against the arm sections 452 and 454 by the horn482 resiliently deflects the arm sections toward the base section 450 ofthe suture retainer 448. This results in the nose portions 468 and 476on the arm sections 452 and 454 moving into engagement with the basesection 450. Protuberances 486 and 488 on the arm sections 452 and 454enable the horn 482 to deflect the arm sections through a sufficientdistance to enable the arm sections to engage the base section 450.

[0303] Once the suture retainer 448 has been securely clamped betweenthe anvil 480 and horn 482, ultrasonic vibratory energy is transmittedfrom the horn 482 to the suture retainer 448. The ultrasonic vibratoryenergy transmitted from the horn 482 to the suture retainer 448 is at afrequency of between 20 kilohertz and 70 kilohertz. It is believed thatit may be preferred to apply ultrasonic vibratory energy at a frequencyof approximately 70 kilohertz or more to the suture retainer 448.

[0304] The ultrasonic vibratory energy transmitted from the horn 482 tothe suture retainer 448 is effective to heat the material of the sutureretainer. The heat tends to be concentrated at the joints between thearm sections 452 and 454 and the base section 450. In addition, the heattends to be concentrated at the joints between the suture sections 442and 444 and the suture retainer 448.

[0305] The material of the suture retainer 448 is heated into atransition temperature range for the material. As the material of thesuture retainer 448 is heated into the transition temperature range, thematerial of the suture retainer softens and becomes pliable. However,the material of the suture retainer 448 does not melt and become aliquid.

[0306] The heat softened material of the suture retainer 448 isplastically deformed by the force applied against the suture retainer bythe anvil 480 and horn 482. As the material of the suture retainer 448is plastically deformed, the recesses 460 and 462 are collapsed. Thematerial of the suture retainer 448 is firmly pressed against the suture440.

[0307] Once the material of the suture retainer 448 adjacent to thesections 442 and 444 of the suture and adjacent to the nose portions 468and 476 on the arm sections has been heated into a transitiontemperature range and plastically deformed, the application ofultrasonic vibratory energy is interrupted. Heating the material of thesuture retainer 448 into its transition temperature range causes thematerial to lose its rigidity and soften. The heat softened material ofthe suture retainer 448 can be deformed by the clamping force applied bythe anvil 480 and horn 482.

[0308] Although the application of ultrasonic vibratory energy to thesuture retainer 448 is interrupted, the suture retainer continues to beclamped between the anvil 480 and horn 482. If desired, the clampingforce applied against the suture retainer 448 by the anvil 480 and horn482 could be increased as the application of ultrasonic vibratory energyto the suture retainer is interrupted.

[0309] As the material of the suture retainer cools, the arm sections452 and 454 of the suture retainer are bonded to the base section 450 ofthe suture retainer. In addition, the arm sections 452 and 454,connector section 456 and base section 450 of the suture retainer 448are bonded to the sections 442 and 444 of the suture 440. This resultsin the suture 440 and the suture retainer 448 being securelyinterconnected.

[0310] In the foregoing description, the suture retainer 448 has beenheated under the influence of ultrasonic vibratory energy transmittedfrom the horn 482 to the suture retainer. It is contemplated that thesuture retainer 448 could also be heated by the direct application ofthermal energy to the suture retainer. For example, a heating elementcould be provided in the anvil 480 and/or the horn 482 to function as aheat source. Alternatively, a heating element could be moved intocontact with the suture retainer 448.

[0311] The anvil 480 and horn 482 do not engage the suture 440. Theanvil 480 and horn 482 engage only the suture retainer 448. Thisprevents excessive heating and deformation of the suture 440. There isno significant deformation of the suture 440 so that it maintains itsstrength.

[0312] Embodiment of FIGS. 18-20

[0313] In the embodiment of the invention illustrated in FIGS. 16 and17, the sections 442 and 444 of the suture 440 are positioned in a pairof recesses 460 and 462 in the suture retainer 448. In the embodiment ofthe invention illustrated in FIGS. 18-20, a single section of a sutureis positioned in a single recess in a suture retainer. Since the sutureretainer of the embodiment of the invention illustrated in FIGS. 18-20is generally similar to the suture retainers of the embodiments of theinvention illustrated in FIGS. 1-17, similar terminology will beutilized to identify similar components. It should be understood thatone or more of the features of the other embodiments of the inventiondisclosed herein could be utilized in association with the embodiment ofthe invention illustrated in FIGS. 18-20.

[0314] A tissue securing system 489 (FIG. 18) is used in a sterile,operating room environment and includes a suture 490 and a sutureretainer 496. The suture 490 (FIG. 18) has a section 492 which isconnected with human body tissue in a manner generally similar to themanner illustrated schematically in FIG. 4. The suture section 492 maybe connected with a suture anchor disposed in engagement with one sideof a layer of body tissue. Alternatively, the suture section 492 may beconnected with a suture anchor which is embedded in body tissue. Thesuture 490 could be connected with a suture anchor having a constructiongenerally similar to the construction of the suture anchors disclosed inU.S. Pat. Nos. 5,584,862; 5,549,631; and/or 5,527,343.

[0315] A one-piece suture retainer 496 includes main sections 498 and500. The main sections 498 and 500 of the suture retainer 496 areinterconnected by a hinge section 502. The suture retainer 496 is formedseparately from the suture 490.

[0316] The main sections 498 and 500 and hinge section 502 of the sutureretainer 496 are integrally formed as one piece. The suture 490 andsuture retainer 496 are both formed of a biodegradable polymer. It isbelieved that it may be preferred to form the suture 490 and sutureretainer 496 from the same amorphous thermoplastic material. However,the suture 490 and suture retainer 496 may be formed of differentamorphous thermoplastic materials having similar chemical properties.The suture 490 and suture retainer 496 may be formed from any of thematerials previously mentioned herein or other materials.

[0317] The main sections 498 and 500 of the suture retainer 496 areinitially skewed at an angle of approximately 30° to each other. Themain sections 498 and 500 cooperate with the hinge section 502 to definea generally V-shaped recess 506 (FIG. 19) in which the section 492 ofthe suture is received. If desired, the recess 506 could have aconfiguration which is different than the illustrated V-shapedconfiguration.

[0318] While a predetermined tension is maintained in the suture 490,the suture retainer 496 is moved along the suture into engagement withthe body tissue, in a manner generally similar to the manner illustratedin FIG. 4 or into engagement with a force distribution member, in themanner generally similar to the manner illustrated in FIG. 5. While apredetermined force is being transmitted from the suture retainer 496 tothe body tissue and while the suture 490 is being tensioned with apredetermined force, the suture 490 is bonded to the suture retainer 496and the main sections 498 and 500 of the suture retainer 496 are bondedtogether.

[0319] To effect securing of the suture 490 by the suture retainer 496,an anvil 512 (FIG. 20) is moved into engagement with the main section498 of the suture retainer 496. At the same time, a horn or acoustictool 514 is moved into engagement with the main section 500 of thesuture retainer 496. The anvil 512 and horn 514 apply force against thesuture retainer 496 to clamp the suture retainer against the suture 490.

[0320] As the anvil 512 and horn 514 are clamped against the sutureretainer 496, the main sections 498 and 500 of the suture retainer aredeflected from the linear configuration illustrated in FIG. 19 to thebent configuration illustrated in FIG. 20. The anvil 512 and horn 514have a configuration which corresponds to the desired configuration ofthe suture retainer 496 when the suture retainer is clamped against thesuture 490 by the anvil and horn.

[0321] The suture retainer 496 is heated to effect a bonding between themain sections 498 and 500 of the suture retainer and to effect asecuring of the suture 490 between the main sections 498 and 500 and thehinge section 502 of the suture retainer. To effect this, ultrasonicvibratory energy is transmitted from the horn 514 to the suture retainer496. The ultrasonic vibratory energy transmitted from the horn 514 tothe suture retainer 496 has a frequency of between 20 kilohertz and 70kilohertz. It is believed that it may be preferred to transmitultrasonic vibratory energy having a frequency of 70 kilohertz or morefrom the horn 514 to the suture retainer 496.

[0322] The ultrasonic vibratory energy transmitted from the horn 514 tothe suture retainer 496 heats the material of the suture retainer. Theheat tends to be concentrated at the joints between the main section 498and 500 of the suture retainer and at the joints between the suture 490and the main sections 498 and 500 and the hinge section 502 of thesuture retainer. The material of the suture retainer 496 is heated intoa transition temperature range for the material.

[0323] When the material adjacent to the main sections 498 and 500 ofthe suture retainer 496 and adjacent to the joint between the suture 490and the suture retainer 496 has been heated into a transitiontemperature range, the application of ultrasonic vibratory energy to thesuture retainer 496 is interrupted. Although the application ofultrasonic vibratory energy from the horn 514 to the suture retainer 496is interrupted, the suture retainer continues to be clamped between theanvil 512 and the horn 514. If desired, the force applied against thesuture retainer 496 by the anvil 512 and horn 514 could be increasedsimultaneously with interruption of ultrasonic vibratory energy to thesuture retainer 496.

[0324] As the material of the suture retainer 496 is heated into itstransition temperature range, the material softens and loses itsrigidity. Although the material of the suture retainer 496 softens asthe material is heated into its transition temperature range, thematerial does not melt and become liquid. As the material of the sutureretainer 496 softens, the force applied against the suture retainer 496by the anvil 512 and horn 514 plastically deforms the suture retainerfrom the configuration illustrated in FIG. 19 to the configurationillustrated in FIG. 20.

[0325] As the material of the suture retainer 496 cools, a bond isformed between the main sections 498 and 500 of the suture retainer. Inaddition, the main sections 498 and 500 and the hinge section 502 of thesuture retainer 496 are bonded to the suture 490. This results in thesuture retainer 496 having a firm grip on the suture 490. The firm gripof the suture retainer 496 on the suture 490 enables a predeterminedtension force to be transmitted through the suture 490 to the bodytissue and enables a predetermined force to be transmitted from thesuture retainer 496 to the body tissue.

[0326] The anvil 512 and horn 514 do not engage the suture 490. Theanvil 512 and horn 514 engage only the suture retainer 496. Thisprevents excessive heating and deformation of the suture 490. The sutureretainer 496 is bonded to the suture 490 without significant deformationof the suture.

[0327] In the embodiment of the invention illustrated in FIGS. 18-20, asingle section 492 of the suture 490 is engaged by the suture retainer496. However, a plurality of sections of suture could be gripped by thesuture retainer 496. Thus, a pair of suture sections, corresponding tothe suture sections 182 and 184 of FIG. 5, could be positioned in therecess 506 (FIG. 19) in the suture retainer 496 and gripped by thesuture retainer. If desired, a force distribution member correspondingto the force distribution member 194 of FIG. 5 could be provided betweenthe suture retainer 496 and the body tissue.

[0328] Embodiment of FIG. 21

[0329] In the embodiment of the invention illustrated in FIGS. 18-20,the suture retainer 496 includes a pair of main sections 498 and 500which are interconnected by a flexible hinge section 502 and whichdefine a recess 506 in which the suture 490 is received. In theembodiment of the invention illustrated in FIG. 21, one section of asuture retainer cooperates with another section of the suture retainerto define a recess in which a suture is received. Since the embodimentof the invention illustrated in FIG. 21 is generally similar to theembodiment of the invention illustrated in FIGS. 1-20, similarterminology will be utilized to identify similar components. It shouldbe understood that one or more of the features of the other embodimentsof the invention illustrated herein could be used with the embodiment ofthe invention illustrated in FIG. 21.

[0330] A tissue securing system 518 is used in a sterile, operating roomenvironment and includes a suture 520 and a suture retainer 528. Thesuture 520 (FIG. 21) includes a section 522 which is connected with bodytissue. The section 522 of the suture 520 may be connected with bodytissue in the manner illustrated schematically in FIG. 4. However, itshould be understood that the suture 520 could be connected with bodytissue in a different manner if desired.

[0331] The suture retainer 528 is formed separately from the suture 520and encloses a portion of the suture. The suture retainer 528 has arectangular configuration and includes a base section 530 and an armsection 532. The base and arm sections 530 and 532 of the sutureretainer 528 are integrally formed as one piece. The arm section 532cooperates with the base section 530 to define a generally U-shapedrecess 534 in which the suture 520 is received.

[0332] The suture retainer 528 may have a configuration which isdifferent than the configuration illustrated in FIG. 21. For example,the suture retainer 528 could have an ovoidal configuration rather thanthe illustrated rectangular configuration. Although the base section 530has been illustrated as being substantially wider than the arm section532, the base and arm sections could be of approximately the same widthif desired. The base and arm sections 530 and 532 could haveconfiguration similar to the configuration of the base section 450 andarm section 452 of FIG. 16 if desired. If desired, the recess 534 couldhave a different configuration. For example, the recess 534 could have aconfiguration similar to the configuration of the recess 460 of FIG. 16.

[0333] The suture retainer 528 may be formed of any one of manydifferent materials, including any of the materials previously mentionedherein. It may be preferred to form the suture retainer 528 of abiodegradable material. The suture 520 may be formed of the samebiodegradable material as the suture retainer 528. It is believed thatit may be preferred to form both the suture 520 and suture retainer 528of an amorphous polymer, such as polyhydroxyalkanoate. Of course, thesuture 520 and suture retainer may be formed of other materials ifdesired.

[0334] When the suture 520 and suture retainer 528 are to be utilized tosecure body tissue, the suture 520 is positioned relative to body tissueby engagement with a suture anchor or other device. The suture 520 isthen positioned in the recess 534 in the suture retainer 528. The suture520 may be positioned in the recess 534 by moving the suture through anentrance to the recess. Alternatively, the suture retainer 528 could bemoved relative to the suture.

[0335] Once the suture 520 has been positioned in the recess 534, apredetermined tension force is applied to the suture 520. The sutureretainer 528 is moved along the suture toward the body tissue. Thesuture retainer is pressed against the body tissue in the mannerillustrated schematically in FIG. 4 or pressed against a forcedistribution member in the manner illustrated schematically in FIG. 5. Apredetermined force is transmitted from the suture retainer 528 to thebody tissue while the predetermined tension is maintained in the suture520.

[0336] To interconnect the suture 520 and suture retainer 528, thesuture retainer is clamped between a horn and anvil of an ultrasonicenergy application apparatus. Ultrasonic energy is then transmitted fromthe horn to the suture retainer 528 in the manner previously describedin conjunction with the embodiments of the invention illustrated inFIGS. 1-20.

[0337] The clamping force applied against the suture retainer 528 by thehorn and anvil deflects the arm section 532 of the suture retainertoward the base section 530 of the suture retainer. The arm sectionmoves into engagement with the base section 530 of the suture retainer528 and firmly grips the suture 520 under the influence of the clampingforce applied by the anvil and horn.

[0338] Ultrasonic energy at a frequency of between 20 kilohertz and 70kilohertz is then applied to the suture retainer 528 by the horn. Theultrasonic vibratory energy heats the material of the suture retainer528 into its transition temperature range. As the material of the sutureretainer 528 is heated into the transition temperature range, thematerial of the suture retainer softens and loses its rigidity. As thisoccurs, the softened material of the suture retainer 528 is plasticallydeformed by the clamping force applied against the suture retainer bythe anvil and horn.

[0339] The transmission of ultrasonic vibratory energy to the sutureretainer 520 is then interrupted. However, the clamping force againstthe suture retainer is maintained and may even be increased.

[0340] As the material of the suture retainer 528 cools, the sutureretainer 528 is securely connected to the suture 520. Thus, the armsection 532 is bonded to the base section 530 of the suture retainer.Both the base section 530 and the arm section 532 are bonded to thesuture 520. This results in the suture retainer 528 having a firm gripon the suture 520 to maintain the tension in the suture and thetransmission of force from the suture retainer to body tissue.

[0341] Embodiment of FIG. 22

[0342] In the embodiment of the invention illustrated in FIG. 21, thearm section 532 is generally straight and cooperates with the basesection 530 to form a recess 534. In the embodiment of the inventionillustrated in FIG. 22, the suture retainer has an arcuate arm sectionwhich cooperates with a base section to form a recess which receives asuture. Since the embodiment of the invention illustrated in FIG. 22 isgenerally similar to the embodiments of the invention illustrated inFIGS. 1-21, similar terminology will be utilized to designate similarcomponents. It should be understood that one or more of the features ofthe other embodiments of the invention disclosed herein could beutilized in conjunction with the embodiment of the invention illustratedin FIG. 22.

[0343] A suture 540 is connected with body tissue in the mannerillustrated schematically in FIG. 4. A suture retainer 542 at leastpartially encloses the suture 540. The suture retainer 542 is integrallyformed as one piece which is separate from the suture 540.

[0344] The suture retainer 542 includes a base section 544 and an armsection 546. The base section 544 and arm section 546 of the sutureretainer are integrally formed as one piece. The suture retainer 542 hasthe same generally rectangular configuration as the suture retainer 528of FIG. 21. However, the suture retainer 542 could have a differentconfiguration if desired.

[0345] The suture retainer 542 may be formed of a biodegradablepolymeric material. It is believed that it may be preferred to form boththe suture 540 and the suture retainer 542 from the same biodegradablepolymeric material. The suture 540 and suture anchor may be formed froman amorphous thermoset polymer. If desired, the suture retainer 542 andsuture 540 could be formed of different polymeric materials which arecompatible with each other. The suture 540 and suture retainer 542 couldbe formed from many different materials, including any of the materialsmentioned herein.

[0346] The arm section 546 of the suture retainer 542 cooperates withthe base section 544 of the suture retainer to define a recess 550 whichreceives a portion of the suture 540. The arm section 546 has a noseportion 554 which partially blocks an entrance 556 to the recess 550.The nose portion 554 on the arm section 546 is effective to retain thesuture 540 in the recess 550.

[0347] When the suture 540 and suture retainer 542 are to be utilized tosecure body tissue, the suture 540 is positioned relative to the bodytissue in a manner similar to that illustrated in FIG. 4. Of course, thesuture 540 could be connected with the body tissue in a different mannerif desired. For example, the suture 540 could be connected with a sutureanchor which is embedded in the body tissue.

[0348] Once the suture 540 has been positioned relative to the bodytissue, the suture is tensioned and positioned in the recess 550 in thesuture retainer 542. To position the suture 540 in the recess 550, thesuture can be moved relative to the recess or the recess can be movedrelative to the suture.

[0349] As the suture 540 moves into the recess 556, the a cylindricalouter side surface of the suture applies force against a cam surface 558on the nose portion 554 of the arm section 546. The force appliedagainst the cam surface 558 deflects the arm section 546 outward awayfrom the base section 544 of the suture retainer 542 to open theentrance 556 to the recess 550. This enables the suture 540 to move intothe recess 550.

[0350] After the suture 540 has moved into the recess 550, the armsection 546 springs back to its initial position, illustrated in FIG.22. When this occurs, the nose portion 554 on the arm section 546partially blocks the entrance 556 to the recess 550 to retain the suture540 in the recess.

[0351] Once the suture 540 has been positioned in the recess 550, thesuture 540 is tensioned with a predetermined force and the sutureretainer 542 is moved along the suture toward the body tissue. Thesuture retainer 542 is moved into engagement with the body tissue in themanner illustrated in FIG. 4 or is moved into engagement with a forcedistribution member in the manner illustrated in FIG. 5. A predeterminedforce is transmitted from the suture retainer 542 to the body tissuewhile the predetermined tension is maintained in the suture 540. Thisresults in layers of body tissue being pressed against each other.

[0352] The suture retainer 542 and suture 540 are then interconnected tomaintain the predetermined tension in the portion of the suture 540connected with the body tissue and to maintain the transmission of thepredetermined force from the suture retainer to the body tissue. Tointerconnect the suture retainer 542 and suture 540, the suture retaineris clamped between an anvil 562 and a horn 564 of an ultrasonic energyapplication apparatus. The clamping force applied against the sutureretainer 542 by the anvil 562 and horn 564 resiliently deflects the armsection 546 so that the nose portion 554 of the arm section moves intoengagement with the base section 544 of the suture retainer. Inaddition, the arm section 546 is firmly pressed against the suture 540.

[0353] While the clamping force is applied to the suture retainer 542 bythe anvil 562 and horn 564, ultrasonic vibratory energy is transmittedfrom the horn to the suture retainer. The ultrasonic vibratory energyhas a frequency of between 20 kilohertz and 70 kilohertz. It is believedthat it may be preferred to utilize ultrasonic vibratory energy having afrequency of approximately 70 kilohertz or more.

[0354] The ultrasonic vibratory energy heats the material of the sutureretainer into its transition range. The heat tends to be concentrated atthe joint between the arm section 546 and the base section 544 of thesuture retainer 542. In addition, the heat is concentrated at the jointbetween the suture 540 and the suture retainer 542.

[0355] Once the material of suture retainer 542 has been softened bybeing heated into its transition temperature range, the application ofultrasonic vibratory energy to the suture retainer is interrupted. Eventhough the application of ultrasonic vibratory energy to the sutureretainer is interrupted, the clamping force applied against the sutureretainer 542 by the anvil 562 and horn 564 is maintained or evenincreased.

[0356] As the material of the suture retainer 542 cools, a secure bondis formed between the arm section 546 and the base section 544 of thesuture retainer. In addition, a secure bond is formed between the suture540 and the base section 544 and arm section 546 of the suture retainer542.

[0357] Embodiment of FIG. 23

[0358] In the embodiments of the invention illustrated in FIGS. 1-22,various types of suture retainers for use in securing a suture relativeto body tissue have been illustrated. The embodiment of the inventionillustrated in FIG. 23 is not limited to any particular suture retainerconstruction. However, similar terminology will be utilized indescribing the components of the embodiment of the invention illustratedin FIG. 23 as were previously utilized in connection with theembodiments of the invention illustrated in FIGS. 1-22.

[0359] In the embodiment of the invention illustrated in FIG. 23, arelatively thick layer of tissue, designated by the numeral 570, is tobe connected with a relatively thin layer of tissue, designated by thenumeral 572. A tissue securing system 574 is utilized to interconnectthe thick and thin layers of tissue. The tissue securing system 574 islocated a precise distance from an end 578 of the thick layer 570 oftissue and an end 580 of the thin layer 572 of tissue.

[0360] In the illustrated embodiment of the invention, the tissuesecuring system 574 is located the same distance from the end 578 of thethick layer of tissue as in which the tissue fixation system is locatedfrom the end 580 of the thin layer of tissue. This results in the twolayers of tissue growing together with a minimum of scarring. Inaddition, the tissue securing system 574 holds the thick layer 570 andthe thin layer 572 of tissue against shifting relative to each other.

[0361] If a staple of loop-type suture was used to interconnect thethick layer 570 and thin layer 572 of tissue, a shifting could occurbetween the two layers of tissue. This shifting could occur inside ofthe loop formed by the suture or the staple. The shifting can result inextensive scarring and could result in a non-uniform repair of thetissue. The obtaining of a uniform repair of tissue is particularlyimportant when interconnecting a conduit, such as a blood vessel, whichhas been severed. By using the tissue securing system 574, shiftingmovement can not occur between the thick layer 570 and thin layer 572 oftissue. This prevents one of the layers from being deflected into thepath of flow of material, such as blood, through the conduit in a mannerwhich restricts the conduit and subsequently results in a blockage.

[0362] The specific tissue securing system 574 illustrated in FIG. 23includes a suture anchor 584 which is disposed in engagement with anouter side surface of the thin layer 572 of tissue. A suture 586 extendsthrough both the thin layer 572 of tissue and the thick layer 570 oftissue. The suture 586 is disposed the same distance from the end 578 ofthe thick layer 570 of tissue as it is located from the end 580 of thethin layer 572 of tissue. A suture retainer 590 is connected with aportion of the suture 586 opposite from the anchor 584. The sutureretainer 590 may have any one of the constructions described herein or adifferent construction.

[0363] In accordance with a feature of the present invention, the sutureretainer 590 is connected with the suture 586 by the application ofultrasonic vibratory energy to the suture retainer 590. The applicationof ultrasonic vibratory energy to the suture retainer 590 results in arapid heating of the material of the suture anchor. The very short timewhich is required to heat the material of the suture retainer 590 by theapplication of ultrasonic vibratory energy enables the suture retainerto be heated into its transition temperature range and softened withoutdetrimentally affecting the layers 570 and 572 of body tissue.

[0364] Although it is contemplated that the amount of heat which isrequired to heat material of the suture retainer 590 into the transitiontemperature range by the application of ultrasonic vibratory energy willvary depending upon the construction of the suture retainer 590, anultrasonic vibratory energy application time of between 0.25 seconds and1.0 seconds is required to connect any one of the suture retainers ofFIGS. 1-22 with a suture. After the suture retainer 590 has been heatedand the application of ultrasonic vibratory energy interrupted, thesuture retainer is allowed to cool for approximately one second. Sincethe suture retainer 590 is heated into its transition temperature rangefor an extremely short period of time, the suture retainer can be heatedto relatively high temperatures which would be detrimental to the layers570 and 572 of the body tissue if the application of ultrasonicvibratory energy was maintained over an extended period of time.

[0365] In the embodiments of the invention illustrated in FIGS. 1, 4 and23, the tissue securing systems are being utilized to interconnectlayers of soft tissue disposed in juxtaposition with each other.However, it contemplated that the tissue securing system could beutilized to interconnect body tissues having different characteristics.For example, the tissue securing system could be utilized to connectsoft tissue, such as a tendon, or ligament, with bone. If the tissuesecuring system was utilized to connect soft tissue with bone, thesuture anchor would engage the bone in a manner similar to thatdisclosed in U.S. Pat. No. 5,403,348 and/or 5,534,012. The suture wouldthen extend from the anchor positioned in the bone into engagement withthe soft body tissue. The suture could be wrapped around the soft bodytissue or, alternatively, could extend through the soft body tissue. Asuture retainer having any of the constructions illustrated in FIGS.1-22 could be connected with one or two sections of the suture to holdthe soft body tissue in place relative to the bone.

[0366] Although it is preferred to connect the suture retainersillustrated in FIGS. 1-22 with a suture, the suture retainers could beconnected with other force transmitting members or directly with bodytissue if desired. For example, any one of the suture retainers of FIGS.1-22 could be connected with a K-wire or a rigid force transmittingmember such as a rod or externally threaded stud. Alternatively, thesuture retainer could be connected directly to body tissue, such as aligament or tendon.

[0367] In the embodiments of the invention illustrated in FIGS. 1-22,the suture retainers have been connected with sutures formed ofpolymeric material. However, the sutures could be formed of metal ifdesired. Thus, the suture retainers illustrated in FIGS. 1-22 could beconnected with any desired type of member which transmits force,including body tissue.

[0368] It is contemplated that the suture retainers illustrated in FIGS.1-22 will be utilized in an operating room environment. The sutureretainers may be positioned within and fully enclosed by a patient'sbody. Alternatively, the suture retainers may be partially disposedoutside of the patient's body.

[0369] Embodiment of FIG. 24

[0370] It is contemplated that the suture retainers of FIGS. 1-23 may beheated by the application of ultrasonic vibratory energy. The ultrasonicvibratory energy may be applied in many different ways. One knownapparatus for applying the ultrasonic vibratory energy to any one of thesuture retainers of FIGS. 1-23 is illustrated schematically in FIG. 24.

[0371] An ultrasonic vibratory energy application apparatus 600 includesa pair of compression members 602 and 604 which are interconnected at apivot connection 606. An anvil or support member 610 is mounted on oneend portion of the member 602. A horn or ultrasonic energy applicationmember 612 is mounted on one end portion of the member 604

[0372] Sections 614 and 616 of a suture retainer are disposed inengagement with the anvil 610 and horn 612. The sections 614 and 616 ofthe suture retainer may have the same construction as the sections 222and 224 of the suture retainer 220 of FIG. 6. When handle end portions620 and 622 of the members 602 and 604 are moved together, the anvils610 and horn 612 press the sections 614 and 616 of the suture retaineragainst sections 626 and 628 of a suture.

[0373] Referring to FIG. 25A, a generator 630 is connected with astandard electrical power supply (120-240 volts). The generator 630converts the standard electrical power supply from 50/60 hertz to anultrasonic frequency, that is a frequency greater than 20 kilohertz. Thehigh frequency electrical energy is conducted through a cable 632 to themember 604.

[0374] Suitable electrically insulated conductors in the member 604conduct the high frequency electrical energy through a transducer (notshown) connected with the horn. The transducer changes the electricalenergy into longitudinal ultrasonic signal resulting in a low amplitudemechanical vibrations. These vibrations may be transmitted to a boosterto increase or decrease the amplitude of the vibrations. The vibrationsare then transmitted to the horn 612.

[0375] The horn 612 has a longitudinal axis 634 along which thelongitudinal ultrasonic signal is propagated. The ultrasonic energy isdirected through the horn 612 to end portion 636 of the horn 612. As aresult the vibrational energy at the end portion 636 of the horn 612 isgreater then the vibrational energy at a side portion 638, wherein theside portion 638 is substantially orthogonal to the end portion 636 ofthe horn 612.

[0376] In an embodiment, the horn 612 is affixed to member 604, suchthat the end portion 636 of the horn 612 presses the sections 614 and616 of the suture retainer against sections 626 and 628 of a suture whenhandle end portions 620 and 622 of the members 602 and 604 are movedtogether. The vibrational energy is transmitted through the end portion636 of the horn 612 to the suture retainer sections 614 and 616.Alternatively, an end deflector is interposed between the end portion636 of the horn 612 and the suture retainer. The end deflector transfersthe energy from the horn 612 to the suture retainer.

[0377] In an embodiment, the horn 612 is affixed to member 604, suchthat the side portion 638 of the horn 612 presses the sections 614 and616 of the suture retainer against sections 626 and 628 of a suture whenhandle end portions 620 and 622 of the members 602 and 604 are movedtogether. The vibrational energy is transmitted through the side portion638 of the horn 612 to the suture retainer sections 614 and 616.Alternatively, an end deflector is interposed between the side portion638 of the horn 612 and the suture retainer. The end deflector transfersthe energy from the horn 612 to the suture retainer.

[0378] Alternatively, the generator 630 converts the energy of thestandard electrical power supply to an ultrasonic frequency. Suitableelectrically insulated conductors in the member 604 conduct the highfrequency electrical energy through a transducer (not shown) connectedwith the horn 612. The transducer changes the electrical energy intotorsional ultrasonic signal resulting in low amplitude mechanicalvibrations.

[0379] The horn 612 is a cylindrical member affixed to member 604, suchthat the side portion 638 of the horn 612 presses the sections 614 and616 of the suture retainer against sections 626 and 628 of a suture whenhandle end portions 620 and 622 of the members 602 and 604 are movedtogether. The torsional ultrasonic signal propagates about thecircumference of the horn 612, wherein the vibrational energy from thetorsional ultrasonic signal is transmitted about the side portion 638 ofthe horn 612 to the suture retainer sections 614 and 616. Alternatively,an end deflector is interposed between the side portion 638 of the horn612 and the suture retainer. The end deflector transfers the energy fromthe horn 612 to the suture retainer.

[0380] It is also contemplated that the above described horn 612 canhave different configurations, including, but not limited to, a hollowcylinder, wherein the torsional ultrasonic signal propagates about thecircumference of the hollow cylinder, and a flattened side portionconfigured for receiving at least one of the suture retainer sections614 and 616 thereon.

[0381] In an embodiment, the ultrasonic vibratory energy applicationapparatus 600 includes a bias member, biasing the anvils 610 and horn612 in a closed position. The suture retainer is loaded in the apparatusby moving the handle end portions 620 and 622 of the members 602 and 604to separate the anvil 610 and horn 612. The suture retainer sections 614and 616 are then disposed in engagement with the anvil 610 and horn 612.The suture retainer can be loaded in the apparatus eitherintra-corporally or extra-corporally.

[0382] When a suture and suture retainer are to be used to secure thehuman body tissue, the suture is positioned relative to the body tissue.The suture sections 626 and 628 are formed separately from the sutureretainer first and second sections 614 and 616. The suture is positionedrelative to human body tissue with the suture sections 626 and 628extending away from an outer side surface of the body tissue. The suturemay be connected with the body tissue in the same manner as illustratedschematically in FIG. 1 if desired. A predetermined tension force isthen applied to the suture sections 626 and 628.

[0383] The suture is positioned in the suture retainer by moving thehandle end portions 620 and 622 of the members 602 and 604 of thevibratory energy application apparatus 600 to separate the anvil 610 andhorn 612. The suture sections 626 and 628 are then positioned inrelation to the suture retainer sections 614 and 616. The bias membermoves the anvils 610 and horn 612 together, pressing suture retainersections 614 and 616 against suture sections 626 and 628. The biasmember compresses the suture retainer sections 614 and 616 together witha compressive force between about 1 lb. to 20 lbs. The suture retainersections 612 and 614 are bonded together and to the suture sections 626and 628 using ultrasonic vibratory energy. The suture can be positionedin the suture retainer either intra-corporally or extra-corporally.

[0384] Embodiment of FIG. 25

[0385] In the embodiment of the invention illustrated in FIG. 24, thehorn and anvil are disposed on a pair of compression members 602 and 604which are pivotally interconnected. In the embodiment of the inventionillustrated in FIG. 25, the horn and anvil of an ultrasonic energyapplication apparatus are movable relative to each other along a linearpath.

[0386] The ultrasonic energy application apparatus 640 of FIG. 25includes a handle 642. A first compression member including a horn 644is connected with the handle 642. A second compression member includingan anvil 646 is integrally formed as one piece with a member 648 whichis movable along a linear path relative to the handle 642. An actuatormember 650 is connected with the member 648 and is movable toward theleft (as viewed in FIG. 25) to move the anvil 646 toward the horn 644.

[0387] Sections 660 and 662 of a suture are disposed between thesections 656 and 658 of the suture retainer. The suture retainer mayhave a construction similar to the construction of the suture retainerillustrated in FIG. 6.

[0388] Referring also to FIG. 25A, a generator 666 is connected with thehandle 642 by a cable 668. The cable 668 connects the generator 666 witha transducer which changes high frequency electrical energy conductedfrom the generator 666 to a longitudinal ultrasonic signal resulting inlow amplitude mechanical vibrations. These vibrations are transmitted toa booster. The vibrations are then transmitted to the horn. The hornapplies the vibrations to the sections 658 of the suture retainer.

[0389] The horn 644 has a longitudinal axis 670 along which theultrasonic signal is propagated. The ultrasonic signal is directedthrough the horn 644 to end portion 672 of the horn 644. As a result thevibrational energy at the end portion 672 of the horn 644 is greaterthen the vibrational energy at a side portion 674, wherein the sideportion 674 is substantially orthogonal to the end portion 672 of thehorn 644.

[0390] In an embodiment, the horn 644 is affixed to the handle 642, suchthat the end portion 670 of the horn 612 presses the sections 656 and658 of the suture retainer against sections 660 and 662 of a suture whenthe actuator member 650 and member 648 are moved toward the left (asviewed in FIG. 25). The vibrational energy is transmitted through theend portion 670 of the horn 644 to the suture retainer sections 656 and658. Alternatively, an end deflector is interposed between the endportion 670 of the horn 644 and the suture retainer. The end deflectortransfers the energy from the horn 644 to the suture retainer.

[0391] In an embodiment, the horn 644 is affixed to the handle 642, suchthat the side portion 672 of the horn 644 presses the sections 656 and658 of the suture retainer against sections 660 and 662 of a suture whenthe actuator member 650 and member 648 are moved toward the right (asviewed in FIG. 25). The vibrational energy is transmitted through theside portion 672 of the horn 644 to the suture retainer sections 656 and658. Alternatively, an end deflector is interposed between the sideportion 672 of the horn 644 and the suture retainer. The end deflectortransfers the energy from the horn 644 to the suture retainer.

[0392] Alternatively, the generator 666 converts the energy of thestandard electrical power supply to an ultrasonic frequency. Suitableelectrically insulated conductors in the conduct the high frequencyelectrical energy through a transducer (not shown) connected with thehorn 644. The transducer changes the electrical energy into torsionalultrasonic signal resulting in low amplitude mechanical vibrations.

[0393] The horn 644 is a cylindrical member affixed to the handle 642,such that the side portion 672 of the horn 644 presses the sections 656and 658 of the suture retainer against sections 660 and 662 of a suturewhen the actuator member 650 and member 648 are moved toward the right(as viewed in FIG. 25). The torsional ultrasonic signal propagates aboutthe circumference of the horn 644, wherein the vibrational energy fromthe torsional ultrasonic signal is transmitted through the side portion672 of the horn 644 to the suture retainer sections 656 and 658.Alternatively, an end deflector is interposed between the side portion672 of the horn 644 and the suture retainer. The end deflector transfersthe energy from the horn 644 to the suture retainer.

[0394] It is also contemplated that the above described horn 644 canhave different configurations, including, but not limited to, a hollowcylinder, wherein the torsional ultrasonic signal propagates about thecircumference of the hollow cylinder, and a flattened side portionconfigured for receiving at least one of the suture retainer sections614 and 616 thereon.

[0395] In an embodiment, the actuator member 650 can include a biasmember, biasing the anvils 646 and horn 644 in a closed position. Thesuture retainer is loaded in the apparatus by moving the actuator member650 to separate the anvil 646 and horn 644. The suture retainer is thenpositioned between the anvil 646 and horn 644. The suture retainer canbe loaded in the apparatus either intra-corporally or extra-corporally.

[0396] When a suture and suture retainer are to be used to secure thehuman body tissue, the suture is positioned relative to the body tissue.The suture is formed separately from the suture retainer. The suture ispositioned relative to human body tissue with the suture extending awayfrom an outer side surface of the body tissue. The suture may beconnected with the body tissue in the same manner as illustratedschematically in FIG. 1 if desired. A predetermined tension force isthen applied to the suture.

[0397] The suture is positioned in the suture retainer by moving theactuator member 650 to separate the anvil 646 and horn 644. The sutureis then positioned in relation to the suture retainer. The bias membermoves the anvils 646 and horn 644 together, pressing suture retaineragainst suture, securing the suture retainer about the suture. The biasmember compresses the suture retainer with a compressive force betweenabout 1 lb. to 20 lbs. The suture can be positioned in the sutureretainer either intra-corporally or extra-corporally.

[0398] It should be understood that the ultrasonic energy applicationapparatus of FIGS. 24 and 25 could have any desired construction. It iscontemplated that ultrasonic energy application apparatus which iscommercially available from Dukane Corporation may be utilized. Ofcourse, ultrasonic energy application apparatus which is commerciallyavailable from other sources may be used if desired. It should beunderstood that the suture retainers of FIGS. 1-23 may be utilized inassociation with any desired ultrasonic energy application apparatus.

[0399] Embodiment of FIGS. 26-28

[0400] In the embodiments of the invention illustrated in FIGS. 1-22, asuture retainer has been utilized to interconnect sections of a suture.In the embodiment of the invention illustrated in FIGS. 26 through 28,the sections of the suture are directly connected to each other. Sincethe embodiment of the invention illustrated in FIGS. 26-28 is generallysimilar to the embodiments of the invention illustrated in FIGS. 1-22,similar terminology will be utilized to identify similar components. Itshould be understood that one or more of the features of otherembodiments of the invention illustrated herein could be used with theembodiment of the invention illustrated in FIGS. 26-28.

[0401] A tissue securing system 680 (FIG. 26) includes a suture 682. Thesuture 682 includes left and right sections 684 and 686 which areinterconnected without using a suture retainer. The two sections 684 and686 may be knotted together and then interconnected. Alternatively, thetwo suture sections may just be interconnected, without knotting in themanner illustrated in FIGS. 27 and 28.

[0402] The tissue securing system 680 secures upper and lower layers 690and 692 of soft, human body tissue in linear apposition with each other.Thus, the two layers 690 and 692 of human body tissue are approximatedand held against movement relative to each other by a suture 682.Although the two layers 690 and 692 of human body tissue have beenschematically illustrated in FIG. 26 as being spaced apart from eachother, they are held in a side-by-side relationship with each other andpressed together by tightening the tissue securing system 680. Pressingthe two layers 690 and 692 together with the tissue securing system 680promotes healing of the tissue.

[0403] Although the tissue securing system 680 has been illustrated inFIG. 26 as being used to hold layers of soft tissue in linear appositionwith each other, it is contemplated that the tissue securing system maybe used in many different locations in a patient's body to securetissue. For example, the tissue securing system 680 could be utilized tosecure soft tissue such as a ligament or tendon against movementrelative to a bone. Alternatively, the tissue securing system 680 couldbe utilized to interconnect portions of a flexible conduit, such as ablood vessel or intestine. It should be understood that the tissuesecuring system 680 may be used with either hard body tissue or softbody tissue or both hard and soft body tissue.

[0404] A force distribution member 694 is disposed between the twosections 684 and 686 of the suture 682. When the suture 682 istensioned, the force distribution member 694 distributes the force overa relatively large area of the upper layer 690 of body tissue. Althoughonly the force distribution member 694 is illustrated in FIG. 26 inassociation with the upper layer 690 of body tissue, a similar forcedistribution member could be provided in association with the lowerlayer 692 of body tissue if desired.

[0405] In accordance with a feature of this embodiment of the invention,the sections 684 and 686 of the suture 682 are interconnected withoutusing a suture retainer similar to the suture retainers illustrated inFIGS. 1-22 herein. In the embodiment of the invention illustrated inFIGS. 26-28, the two sections 684 and 686 of the suture 682 are heated,flattened, and bonded together. Heating the suture sections 684 and 686softens the material of the suture sections and allow them to beplastically deformed from a cylindrical configuration to a flat,generally planar configuration. Flattening the cylindrical sections 684and 686 of the suture 682 increases the area at which the suturesections can be interconnected and thereby increases the strength of theconnection between the suture sections.

[0406] The suture 682 may be formed of many different materials,including the materials previously mentioned herein. The suture 682 maybe formed of either a biodegradable or a non-biodegradable material. Itis believed that it will be preferred to form the suture 682 of abiodegradable material. It may be preferred to form the suture 682 of abiodegradable amorphous polymer. For example, the suture 682 could beformed of polyhydroxyalkanoate. Of course, the suture 682 could beformed of other materials if desired. Additionally, the suture 682 maybe a monofilament or multifilament, being formed of a plurality ofinterconnected filaments.

[0407] When the suture 682 is to be connected with the layers 690 and692 of body tissue, the suture is positioned as illustratedschematically in FIG. 26. The sections 684 and 686 of the suture 682 aretensioned with a predetermined force. While the sections 684 and 686 ofthe suture are being tensioned, the force distribution member 694 ispressed against the upper layer 690 of body tissue. This results in theupper and lower layers 690 and 692 of the body tissue being compressedtogether with a predetermined force.

[0408] Once the layers 690 and 692 have been pressed together with apredetermined force by tensioning the sections 684 and 686 of the suture682 and pressing the force distribution member 694 against the bodytissue, the sections of the suture are interconnected. To interconnectthe sections 684 and 686 of the suture 682, the two sections are pulledtight across the force distribution member and disposed in anoverlapping relationship. An anvil 700 is positioned on one side of thetwo sections 684 and 686 of the suture 682. A horn 702 is positioned onthe opposite side of the sections 684 and 686 of the suture 682. Theanvil 700 and horn 702 are pressed against the opposite sides of thesuture 682 with a predetermined force.

[0409] The suture sections 684 and 686 are stacked in a side-by-siderelationship between the anvil 700 and horn 702. The anvil 700 engagesone suture section and the horn 702 engages the other suture section.Thus, the anvil 700 may engage the suture section 684 and the horn 702my engage the suture section 686.

[0410] While the sections 684 and 686 of the suture 682 are clampedbetween the anvil 700 and horn 702, ultrasonic vibratory energy istransmitted from the horn 702 to the sections 684 and 686 of the suture.At this time, the suture sections are tensioned with a predeterminedforce. The ultrasonic vibratory energy is at a frequency of between 20kilohertz and 70 kilohertz. It is believed that it may be preferred totransmit ultrasonic vibratory energy to the sections of the suture 682at a frequency of 70 kilohertz or more.

[0411] The ultrasonic vibratory energy transmitted from the horn 702 tothe suture 682 is effective to heat the material of the suture into itstransition temperature range. As the material of the suture 682 isheated into its transition temperature range, the material loses itsrigidity and softens. However, the material of the suture 682 does notmelt and become a liquid as it is heated into the transition temperaturerange.

[0412] The heated and softened material of the sections 684 and 686 ofthe suture 682 are flattened from the cylindrical configuration of FIG.27 to form thin layers which are disposed in a side-by-side relationshipand have a generally plate-like configuration which is illustratedschematically in FIG. 28. Thus, the section 684 of the suture isflattened to form a layer 706 having an upper major side surface 708which extends parallel to a lower major side surface 710 of the layer706. Similarly, the section 686 of the suture 682 is flattened to form alayer 714 having a flat upper major side surface 716 which extendsparallel to a lower major side surface 718 of the layer 714.

[0413] As the section 684 of the suture 682 is flattened, it is extendedsideways in opposite directions along a path which extends perpendicularto a central axis 722 (FIG. 28) of the suture section 684. Similarly, asthe section 686 of the suture 682 is flattened, it is extended sidewaysin opposite directions along a path which extends perpendicular to acentral axis 724 of the suture section 686. Although the flattenedsuture sections 684 and 686 have been illustrated as having planar majorside surfaces 708, 710, 716 and 718, the suture sections could beflattened in such a manner as to have arcuately curving major sidesurfaces. For example, the major side surfaces 708, 710, 716 and 718 ofthe flattened suture sections 684 and 686 could curve upward (as viewedin FIG. 27) away from the body tissue 690.

[0414] The side surfaces 708, 710, 716 and 718 all have a relativelylarge area. The area of each unit of length as measured along alongitudinal central axes 722 and 724 of the suture sections at the sidesurfaces 708, 710, 716 and 718, is greater than the corresponding areaof a unit of length of the section of the suture having the cylindricalconfiguration illustrated in FIG. 27.

[0415] Thus, a one-inch length of a cylindrical portion of the suture682 has a circumferential area of pi (3.1416) times the diameter of thecylindrical section 684 of the suture 682. A one inch length, asmeasured along a longitudinal central axis 722 of the suture section684, of the upper side surface 708 of the layer 706 has an area which isgreater than pi (3.1416) times the diameter of the cylindrical portionof the suture 682. Similarly, a unit of length of the upper major sidesurface 716 of the layer 714 is greater than the area of a unit oflength of the cylindrical portion of the suture 682.

[0416] When the sections 684 and 686 of the suture 682 have been heatedand flattened from the cylindrical configuration of FIG. 27 to theplastically deformed and flattened configuration of FIG. 28 by the anvil700 and horn 702, the application of ultrasonic vibratory energy to thelayers 706 and 708 by the horn 702 is interrupted. As the material ofthe layers 706 and 714 cools, a secure bond is formed between the layers706 and 714 throughout the extent of the lower major side surface 710 ofthe upper layer 706 and the upper major side surface 716 of the lowerlayer 714. The relatively large area of the bond between the two layers706 and 714 provides a strong interconnection between the two suturesections 684 and 686.

[0417] In the foregoing description, the sections 684 and 686 wereheated, under the influence of ultrasonic vibratory energy transmittedfrom the horn 702, and flattened to have surface areas which are greaterthan the surface area of a corresponding length of a cylindrical portionof the suture 682. However, it is contemplated that the sections 684 and686 of the suture 682 could be flattened to a lesser extent. If this wasdone, the area of one of the major side surfaces, for example the lowermajor side surface 710 of the layer 706, might not be as great as thearea of a corresponding length of a cylindrical portion of the suture682. Thus, the sections 684 and 686 of the suture 682 may be flattenedand extended sideways to a greater or lesser extent. Even a relativelysmall extent of flattening of the sections 684 and 686 of the suture 682will result in an increase in the area at which the two sections of thesuture are bonded together. This is because the circumferential extentof a bond formed between a pair of cylindrical surfaces disposed intangential engagement is relatively small. The extent of the bondbetween the surfaces 710 and 716 is relatively large even though thesurfaces have a smaller extent than illustrated in FIG. 28.

[0418] Embodiment of FIGS. 30A-30B

[0419] Referring to FIGS. 30A-30B, the suture retainer 740 includes afirst section 742 and a second section 744 formed separately from eachother. However, it is contemplated that the two sections 742 and 744could be interconnected by a flexible connector section. The flexibleconnector section may be formed as one piece with the first section 742and the second section 744 of the suture retainer 740.

[0420] The first section 742 of the suture retainer 740 includes a topsurface 746 and a bottom surface 748. The bottom surface 748 includes apair of parallel channels 750 and 752 extending along the length of thebottom surface 748. The parallel channels 750 and 752 are divided by acenter extension 754 extending along the length of the bottom surface748.

[0421] The second section 744 of the suture retainer 740 includes a topsurface 756 and a bottom surface 758, wherein the top surface 756includes a center channel 760 configured for receiving the centerextension 754 of the first section 742. The width of the second section744 is less then the width of the first section 742, such that thesecond section 744 is positionable within the first section 742.

[0422] The end portion of the center extension 754 has a pointedconfiguration. Thus, the end portion of the center extension 754terminates in a tip. Therefore, there is line contact between the of thecenter extension 754 and the end of the center channel 760.

[0423] By forming the end portion of the center extension 754 with apointed configuration, the end portion of the center extension 754 iseffective to function as energy director for ultrasonic vibratoryenergy. The pointed end of the center extension 754 is effective todirect ultrasonic vibratory energy transmitted from the first section742 of the suture retainer 740 to the end portion of the centerextension 754 and center channel 760. The pointed configuration of theend portion of the center extension 754 concentrates the energy andfacilitates melting of the material of the projections. To a lesserextent, the material of the second section 744 of the retainer 740 ismelted adjacent to the bottom surfaces of the center channel 760. Thisresults in a secure bonding and interconnection between the first andsecond sections 742 and 744 of the retainer 740.

[0424] When a suture 762 and suture retainer 740 are to be used tosecure human body tissue, the suture 762 is positioned relative to thebody tissue. The suture includes ends 764 and 766 which are formedseparately from the first and second sections 742 and 744 of the sutureretainer 740. The suture 762 is positioned relative to human body tissuewith the ends 764 and 766 extending away from an outer side surface ofthe body tissue. The suture 762 may be connected with the body tissue inthe same manner as illustrated schematically in FIG. 1 if desired. Apredetermined tension force is then applied to the ends 764 and 766 ofthe suture 762.

[0425] The two sections 742 and 744 of the suture retainer 740 arepositioned in engagement with the suture ends 764 and 766, wherein thesuture ends 764 and 766 are positioned one each in the parallel channels750 and 752 of the first section 742 of the suture retainer 740. Thesecond section 744 of the suture retainer 740 engages the first section742 of the suture retainer 740 such that the center extension 754 ispositioned within the center channel 760 and the suture ends 764 and 766are interposed between the bottom surface 748 of the first section 742and the top surface 756 of the second section 744 of the suture retainer740. The suture retainer 740 is pressed against the body, resulting inthe body tissue being pressed between the suture retainer 740 and theportion of the suture 762 connected with the body tissue. A forcedistribution member could be provided between the suture retainer 740and body tissue if desired.

[0426] In order to bond the suture retainer sections 742 and 744 to eachother and to the suture ends 764 and 766, ultrasonic vibratory energy istransmitted to the suture retainer 740. To effect the transmission ofultrasonic vibratory energy to the suture retainer sections 742 and 744,an anvil 768 is moved into engagement with the second section 744 of thesuture retainer 740. A horn or acoustic tool 770 is moved intoengagement with the first section 742 of the suture retainer 740.Alternatively, the anvil 768 can engage the first section 742 and thehorn 770 can engage the second section 744. The anvil 768 and horn 770are pressed against the suture retainer sections 742 and 744 with apredetermined force to firmly press the sections 742 and 744 against thesuture ends 764 and 766.

[0427] While the anvil 768 and horn 770 are being pressed against thesuture retainer sections 742 and 744 with a predetermined force,ultrasonic vibrations are transmitted from the horn 770 to the sutureretainer 740. The ultrasonic vibrations transmitted to the sutureretainer 740 create frictional heat and cause portions of the materialof the suture retainer 740 to be heated into the transition temperaturerange for the material. As the material of the suture retainer 740 isheated into its transition temperature range, the material loses some ofits rigidity and softens. The material of the suture retainer 740 doesnot melt and become liquid. The heat in the suture retainer 740 willtend to be concentrated adjacent to the channels 750, 752, and 760 andthe center extension 754.

[0428] As the material of the suture retainer 740 is heated and softenedby the ultrasonic vibratory energy, the suture retainer sections 742 and744 are pressed together by force applied by the anvil 768 and horn 770.As this occurs, the material of the suture retainer sections 742 and 744is plastically deformed and pressed against the suture ends 764 and 766at the channels 750 and 752 in the suture retainer 740. At the sametime, at least portions of the bottom surface 748 of the first section742 and the top surface 756 of the second section 744 of the sutureretainer 740 will move into engagement with each other.

[0429] When this has occurred, the transmission of ultrasonic energy tothe suture retainer 740 is interrupted. However, the force appliedagainst the suture retainer sections 742 and 744 is maintained. It isbelieved that it may be desired to increase the force applied againstthe suture retainer sections 742 and 744 by the anvil 768 and horn 770as the application of ultrasonic vibratory energy to the suture retainer740 is interrupted. For example, the force applied to the sutureretainer 740 can be substantially between 1 to 20 lbs.

[0430] While the clamping force applied by the anvil 768 and horn 770 ismaintained, the first and second sections 742 and 744 of the sutureretainer 740 bond to each other. In addition, the first and secondsections 742 and 744 of the suture retainer 740 are compressed about thesuture ends 764 and 766. This results in the suture 762 being firmlygripped by the suture retainer sections 742 and 744. The suture retainersections 742 and 744 secures to the suture 762 without significantdeformation of the suture 762.

[0431] Embodiment of FIG. 31

[0432] Referring to FIG. 31, the suture retainer 780 includes a firstsection 782 and a second section 784 formed separately from each other.However, it is contemplated that the two sections 782 and 784 could beinterconnected by a flexible connector section. The flexible connectorsection may be formed as one piece with the suture retainer firstsection 782 and the second section 784.

[0433] The first section 782 of the suture retainer 780 includes a topsurface 786 and a bottom surface 788. The bottom surface 788 includes apair of parallel extensions 790 and 792 extending substantially alongthe length of the bottom surface 788.

[0434] The second section 784 of the suture retainer 780 includes a topsurface 794 and a bottom surface 796, wherein the top surface 794includes a pair of parallel channels 798 and 800. The parallel channels798 and 800 are configured for receiving the parallel extensions 790 and792 of the first section 782.

[0435] The end portions of the parallel extensions 790 and 792 each havea pointed configuration. Thus, the end portions of the parallelextensions 790 and 792 each include a flat side surface area whichintersects a flat side surface area at a linear point or peak.Therefore, there is line contact between the end portions and the flatbottom surface of the parallel channels 798 and 800.

[0436] By forming the end portions of the parallel extensions 790 and792 with a pointed configuration, the end portions are effective tofunction as energy directors for ultrasonic vibratory energy. Thepointed end portions of the parallel extensions 790 and 792 areeffective to direct ultrasonic vibratory energy transmitted from thefirst section 782 of the suture retainer 780 to the ends of the parallelextensions 790 and 792 and to the bottom surfaces of the parallelchannels 798 and 800. The pointed configuration of the end portions ofthe parallel extensions 790 and 792 concentrates the energy andfacilitates melting of the material of the parallel extensions 790 and792. To a lesser extent, the material of the second section 784 of theretainer 780 is melted adjacent to the parallel channels 798 and 800.This results in a secure bonding and interconnection between the firstand second sections 782 and 784 of the retainer 780.

[0437] When a suture 802 and suture retainer 780 are to be used tosecure the human body tissue, the suture 802 is positioned relative tothe body tissue. The suture 802 includes ends 804 and 806 which areformed separately from the suture retainer first and second sections 782and 784. The suture 802 is positioned relative to human body tissue withthe ends 804 and 806 extending away from an outer side surface of thebody tissue. The suture 802 may be connected with the body tissue in thesame manner as illustrated schematically in FIG. 1 if desired. Apredetermined tension force is then applied to the suture ends 804 and806.

[0438] The suture retainer sections 782 and 784 are positioned inengagement with the suture ends 804 and 806, wherein the suture ends 804and 806 are interposed between the parallel extensions 790 and 792 ofthe suture retainer first section 782. The suture retainer first section782 engages the suture retainer second section 784, such that theparallel extensions 790 and 792 are positioned within the parallelchannels 798 and 800 and the suture ends 802 and 804 are interposedbetween the bottom surface 788 of the first section 782 and the topsurface 794 of the second section 784 of the suture retainer 780. Thesuture retainer 780 is pressed against the body, resulting in the bodytissue being pressed between the suture retainer 780 and the portion ofthe suture 802 connected with the body tissue. A force distributionmember could be provided between the suture retainer 780 and body tissueif desired.

[0439] The suture retainer sections 782 and 784 are bonded togethersecuring the suture ends 804 and 806 using ultrasonic vibratory energytransmitted to the suture retainer 780 as previously described inrelation to FIGS. 30A-30B. However, in the present embodiment the heatin the suture retainer 780 will tend to be concentrated adjacent to theparallel extensions 790 and 792 and the parallel channels 798 and 800.

[0440] Embodiment of FIG. 32

[0441] Referring to FIG. 32, the suture retainer 810 includes a firstsection 812 and a second section 814 formed separately from each other.However, it is contemplated that the two sections 812 and 814 could beinterconnected by a flexible connector section. The flexible connectorsection may be formed as one piece with the first section 812 and thesecond section 814 of the suture retainer 810.

[0442] The first section 812 of the suture retainer 810 includes a topsurface 816 and a bottom surface 818. The bottom surface 818 includes acenter post 820 extending therefrom. The second section 814 of thesuture retainer 810 includes a top surface 822 and a bottom surface 824,wherein the top surface 822 includes a center flange 826 defining apassage 828 configured for receiving the center post 820.

[0443] The end portion of the center post 820 has a pointedconfiguration. Thus, the end portion of the center post 820 includes asubstantially conical shape forming a point. Therefore, there is a pointof contact between the end portion of the center post 820 and the flatbottom surface of the passage 828 of the second section 814.

[0444] By forming the end portion of the center post 820 with a pointedconfiguration, the end portion of the center post 820 is effective tofunction as energy director for ultrasonic vibratory energy. The pointedend portion of the center post 820 is effective to direct ultrasonicvibratory energy transmitted from the first section 812 to the ends ofthe center post 820 to the bottom surfaces of the passage 828 of thesecond section 814. The pointed configuration of the end portion of thecenter post 820 concentrates the energy and facilitates melting of thematerial of the center post 820. To a lesser extent, the material of thesecond section of the retainer 810 is melted adjacent to the bottomsurfaces of the passage 828. This results in a secure bonding andinterconnection between the first and second sections 812 and 814 of theretainer 810.

[0445] When a suture 830 and suture retainer 810 are to be used tosecure the human body tissue, the suture 830 is positioned relative tothe body tissue. The suture 830 includes ends 832 and 834 which areformed separately from the suture retainer first and second sections 812and 814. The suture 830 is positioned relative to human body tissue withthe ends 832 and 834 extending away from an outer side surface of thebody tissue. The suture 830 may be connected with the body tissue in thesame manner as illustrated schematically in FIG. 1 if desired. Apredetermined tension force is then applied to the suture ends 832 and834.

[0446] In use, the suture ends 832 and 834 are wrapped around the centerpost 820 of the suture retainer first section 812. The center post 820and wrapped suture ends 832 and 834 are inserted into the passage 828 onthe top surface 822 of the suture retainer second section 814. Thesuture retainer 810 is pressed against the body, resulting in the bodytissue being pressed between the suture retainer 810 and the portion ofthe suture 830 connected with the body tissue. A force distributionmember could be provided between the suture retainer 830 and body tissueif desired.

[0447] The suture retainer sections 812 and 814 are bonded togethersecuring the suture ends 832 and 834 using ultrasonic vibratory energytransmitted to the suture retainer 810 as previously described inrelation to FIGS. 30A-30B. However, in the present embodiment the heatin the suture retainer 810 will tend to be concentrated adjacent to thecenter post 820 and passage 828.

[0448] Embodiment of FIGS. 33A-33B

[0449] Referring to FIGS. 33A-33B, the suture retainer 840 includes afirst section 842 and a second section 844 formed separately from eachother. The first section 842 of the suture retainer 840 includes a firstend 846, a second end 848, and a first and second surface 850 and 852interposed between the first and second ends 846 and 848. The secondsection 844 of the suture retainer 840 includes a first end 854, asecond end 856, and a first and second surface 858 and 860 interposedbetween the first and second ends 854 and 856. The first section firstend 846 and the second section first end 854 are coupled such that thefirst section second surface 850 and the second section first surface858 are facing each other. The first section second end 848 can includean engagement member 861 configured for engaging the second section topsurface 858.

[0450] The end portion of the engagement member 861 has a pointedconfiguration. Thus, the engagement member 861 includes a flat sidesurface area which intersects a flat side surface area at a linear pointor peak. Therefore, there is line contact between the end portion of theengagement member 861 and the second section top surface 858.

[0451] By forming the end portion of the engagement member 861 with apointed configuration, the end portion of the engagement member 861 iseffective to function as energy director for ultrasonic vibratoryenergy. The pointed end portion of the engagement member 861 iseffective to direct ultrasonic vibratory energy transmitted from thefirst section 842 to the second section top surface 858. The pointedconfiguration of the end portion of the engagement member 861concentrates the energy and facilitates melting of the material of theengagement member 861. To a lesser extent, the material of the secondsection of the retainer 840 is melted adjacent to the engagement member861. This results in a secure bonding and interconnection between thefirst and second sections 842 and 844 of the retainer 840.

[0452] When a suture 862 and suture retainer 840 are to be used tosecure the human body tissue, the suture 862 is positioned relative tothe body tissue. The suture 862 includes ends 864 and 866 which areformed separately from the suture retainer first and second sections 842and 844. The suture 862 is positioned relative to human body tissue withthe ends 864 and 866 being substantially parallel to an outer sidesurface of the body tissue, such that the suture 862 forms a loop. Thesuture 862 may be connected with the body tissue in the same manner asillustrated schematically in FIG. 1 if desired. A predetermined tensionforce is then applied to the suture ends 864 and 866.

[0453] The suture retainer sections 842 and 844 are positioned inengagement with the suture ends 864 and 866, wherein the suture ends 864and 866 are interposed between the first section second surface 850 andthe second section first surface 858, wherein the engagement member 861hold the suture 862 within the suture retainer 840.

[0454] The suture retainer sections 842 and 844 are bonded togethersecuring the suture ends 864 and 866 using ultrasonic vibratory energytransmitted to the suture retainer 840 as previously described inrelation to FIGS. 30A-30B. The anvil and horn engage the first sectionfirst surface 846 and the second section second surface 852. The anviland horn are pressed against the first section first surface 846 and thesecond section second surface 852 with a predetermined force to firmlypress the first section second surface 848 and the second section firstsurface 850 against the ends 864 and 866 of the suture 862.

[0455] In an alternative embodiment, as shown in FIGS. 37A-37B, thesuture retainer first section 842 and second section 844 are hingedlyconnected. The hinged section 868 collapses when the first sectionsecond surface 850 and the second section first surface 858 arecompressed together, such that the first section second surface 850 andthe second section first surface 858 remain substantially parallel.Additionally, the first section second surface 850 and the secondsection first surface 858 can include opposing serrated surfaces 870.The opposing serrated surfaces 870 are configured to grip the sutureends 864 and 866 when compressed. The opposing serrated surfaces alsoincrease the surface area of the first section second surface 850 andthe second section first surface 858, providing an increase bonding areafor welding.

[0456] Embodiment of FIGS. 34A-34B

[0457] Referring to FIGS. 34A-34B, the suture retainer 880 has agenerally rectangular configuration and includes a top surface 882 and abottom surface 884, with the top surface 882 including a pair ofparallel grooves 886 and 888 extending along the length of the sutureretainer 880. The parallel grooves 886 and 888 each have a radius whichis greater than the radius of the suture 890. The major side surfaces892 and 894 of the grooves 886 and 888 are greater than the diameter ofthe suture, such that each of the suture ends 896 and 898 are disposedone each in grooves 886 and 888.

[0458] The end portions of the major side surfaces 892 and 894 of thegrooves 886 and 888 each have a pointed configuration. Thus, the endportions major side surfaces 892 and 894 of the grooves 886 and 888 eachinclude a flat side surface area which intersects a flat side surfacearea at a linear point or peak. Therefore, there is line contact betweenthe end portions and horn 902.

[0459] The suture retainer 880 is positioned in an engagement with thesuture, wherein the suture ends 896 and 898 are disposed within thegrooves 886 and 888. The suture retainer 880 is pressed against the bodytissue with a predetermined force. This results in the body tissue beingpressed between the suture retainer 880 and the portion of the suture890 connected with the body tissue. A force distribution member could beprovided between the suture retainer 880 and body tissue if desired.

[0460] When the suture and suture retainer 880 are to be used to securethe human body tissue, the suture is positioned relative to the bodytissue. The suture may be positioned relative to the body tissue in themanner illustrated schematically in FIG. 1. A predetermined tensionforce is then applied to the suture ends sections 896 and 898 of thesuture.

[0461] To effect the transmission of ultrasonic vibratory energy to thesuture retainer 880, an anvil 900 is moved into engagement with thesuture retainer bottom surface 884. A horn or acoustic tool 902 is movedinto engagement with the suture retainer top surface 882. The anvil 900and horn 902 are pressed against the suture retainer top surface 882 andbottom surface 884 with a predetermined force.

[0462] While the anvil 900 and horn 902 are being pressed against thesuture retainer 880 with a predetermined force, ultrasonic vibrationsare transmitted from the horn 902 to the suture retainer 880. Theultrasonic vibrations transmitted to the suture retainer 880 createfrictional heat and cause portions of the material of the sutureretainer 880 to be heated into the transition temperature range for thematerial. As the material of the suture retainer 880 is heated into itstransition temperature range, the material loses some of its rigidityand softens. The material of the suture retainer 880 does not melt andbecome liquid. The heat in the suture retainer 880 will tend to beconcentrated adjacent to the grooves 886 and 888 in the major sidesurfaces 892 and 894.

[0463] As the material of the suture retainer 880 is heated and softenedby the ultrasonic vibratory energy, the major side surfaces 892 and 894are compressed by a force applied against the anvil 900 and horn 902.For example, the force applied to the suture retainer 880 can besubstantially between 1 to 20 lbs. As this occurs, the material of themajor side surfaces 892 and 894 is plastically deformed and pressed overthe suture ends 896 and 898 and the grooves 886 and 888 in the sutureretainer 880.

[0464] When this has occurred, the transmission of ultrasonic energy tothe suture retainer 880 is interrupted. However, the force appliedagainst the suture retainer 880 top surface 882 and bottom surface 884is maintained. It is believed that it may be desired to increase theforce applied against the top surface 882 and bottom surface 884 by theanvil 900 and horn 902 as the application of ultrasonic vibratory energyto the suture retainer 880 is interrupted. While the clamping forceapplied by the anvil 900 and horn 902 is maintained or increased, thedeformed suture retainer 880 secures the suture ends 896 and 898 withoutsignificant deformation of the suture.

[0465] To facilitate the flow of the plastically deformed sections ofthe suture retainer 880 over the suture ends 896 and 898 and the sutureretainer grooves 886 and 888, the horn 902 can include shaped sections.The horn 902 includes a first and second curved section 904 and 906 forengaging the major side surfaces 892 and 894 of the suture retainer 880.The first and second curved sections 904 and 906 are shaped to force theplastically deformed major side surfaces 892 and 894 over the sutureends 886 and 888 and the grooves 886 and 888 when the force is applied.

[0466] Embodiment of FIG. 35

[0467] Referring to FIG. 35, the suture retainer 910 has a generallyrectangular configuration and includes a top surface 912 and a bottomsurface 914, wherein the top surface includes a pair of parallel grooves916 and 918 separated by a center extension 920 such that one each ofthe suture ends 922 and 924 are disposed in a groove 916 and 918.

[0468] The suture retainer 910 is positioned in an engagement with thesuture, wherein the suture ends 922 and 924 are disposed with thegrooves 916 and 918. The suture retainer 910 is pressed against the bodytissue with a predetermined force. This results in the body tissue beingpressed between the suture retainer 910 and the portion of the sutureconnected with the body tissue. A force distribution member could beprovided between the suture retainer 910 and body tissue if desired.

[0469] The suture retainer 910 secures to the suture ends 922 and 924using ultrasonic vibratory energy transmitted to the suture retainer 910as previously described in relation to FIGS. 34A-34B. However, in thepresent embodiment the heat in the suture retainer 910 will tend to beconcentrated adjacent to the center extension 920. As this occurs, thematerial of the center extension 920 of the suture retainer 910 isplastically deformed and pressed over the suture ends 922 and 924 andthe suture retainer grooves 916 and 918.

[0470] To facilitate the flow of the plastically deformed sections ofthe suture retainer 910 over the suture ends 922 and 924 and the sutureretainer grooves 916 and 916, the horn 926 can include shaped sections.The horn 926 includes a first and second curved section 928 and 930separated by a point tip 932 for engaging the suture retainer centerextension 920. The pointed tip 932 of the horn 926 directs theultrasonic energy into the center extension 920. As the center extension920 is heated, the first and second curved sections 928 and 930 areshaped to force the plastically deformed center extension 920 over thesuture ends 922 and 924 and the suture retainer grooves 916 and 916 whenthe force is applied.

[0471] It is contemplated that the horn can include any shaped sectionwhich focus the energy and directs the plastically deformed section ofthe suture retainer over the suture ends, securing the suture retainerand the suture end. Referring to FIGS. 36A-36C, exemplary horn shapesare provided which include, but are not limited to, a convex surface, aconcave surface, a triangular surface, inverted triangular surface, etc.

[0472] The suture retainer of the present invention can include atextured surface. The textured surface increases the surface area,thereby providing an increased bonding area. For example, as shown inFIGS. 37A and 37B, the first section second surface 850 and the secondsection first surface 858 of the suture retainer 840 includes a texturesurface, namely a serrated surface. The textured surface increasessurface areas of the first section second surface 850 and the secondsection first surface 858, providing an increased bonding area. Thetextured surface can include any geometric pattern which provides anincrease in surface bonding area. Additionally, texture surface providesan increase in the surface friction between the suture retainer and thesuture.

[0473] Embodiment of FIG. 38

[0474] Referring to FIG. 38, the suture retainer 940 is a heat shrinkmaterial, wherein the suture retainer 940 is wrapped around the suture942. While the suture 942 is being pulled straight under the influenceof tension in the suture due to the force and while the suture retainer940 is being pressed against the upper layer of body tissue or against asuitable force distribution member, the suture retainer 940 is heated,causing the suture retainer to shrink around and grip the suture 940. Inaccordance with one of the features of the invention, the sutureretainer 940 is heated by the application of ultrasonic vibratory energyto the suture retainer. The ultrasonic vibratory energy is convertedinto heat by the molecules of the suture retainer 940. Thus, themechanical ultrasonic vibrations applied against the suture retainer 940cause molecular vibration of the material of the suture retainer and aheating of the suture retainer.

[0475] The suture retainer 940 can be substantially cylindrical inshape, wherein the suture ends 944 and 946 are inserted through thesuture retainer 940. Additionally, the suture retainer can be of othergeometric shapes configured for receiving the suture.

[0476] Embodiment of FIG. 39

[0477] In the previous embodiments, a suture retainer and suture hasbeen utilized to interconnect sections of a suture to secure tissuesegments. In the embodiment of the invention illustrated in FIG. 39, thetissue securing system includes a retainer device 960 to secure bodytissue, either soft body tissue to soft body tissue or soft body tissueto hard body tissue.

[0478] The retainer device 960 includes first and second sections 962and 964 interconnected by a mid-section 966. The first section 962includes an engagement member 968 and the second section 964 includesslotted member 970 configured for receiving the engagement member 968.

[0479] The end portion of the engagement member 968 has a pointedconfiguration. Thus, the engagement member 968 includes a flat sidesurface area which intersects a flat side surface area at a linear pointor peak. Therefore, there is line contact between the end portion of theengagement member 968 and the second section slotted member 970.

[0480] By forming the end portion of the engagement member 968 with apointed configuration, the end portion of the engagement member 968 iseffective to function as energy director for ultrasonic vibratoryenergy. The pointed end portion of the engagement member 968 iseffective to direct ultrasonic vibratory energy transmitted from thefirst section 962 to the second section slotted member 970. The pointedconfiguration of the end portion of the engagement member 968concentrates the energy and facilitates melting of the material of theengagement member 968. To a lesser extent, the material of the secondsection 964 of the retainer 960 is melted adjacent to the slotted member970. This results in a secure bonding and interconnection between thefirst and second sections 982 and 964 of the retainer 960.

[0481] The retainer device 960 secures upper and lower layers of soft,human body tissue in linear apposition with each other. Thus, the twolayers of human body tissue are approximated and held against movementrelative to each other by retainer device 960. Pressing the two layerstogether with the retainer device 940 promotes healing of the tissue.

[0482] Although the retainer device 960 has been described as being usedto hold layers of soft tissue in linear apposition with each other, itis contemplated that the tissue securing system may be used in manydifferent locations in a patient's body to secure tissue. For example,the retainer device 960 could be utilized to secure soft tissue such asa ligament or tendon against movement relative to a bone. Alternatively,the retainer device 960 could be utilized to interconnect portions of aflexible conduit, such as a blood vessel or intestine. It should beunderstood that the retainer device 960 may be used with either hardbody tissue or soft body tissue or both hard and soft body tissue.

[0483] In use, the retainer device 960 is used to secure the layers ofsoft tissue, by passing the first and second sections 962 and 964through the tissue layers. The mid-section 966 of the retainer device960 should proximate to the upper service of the upper tissue layer.

[0484] In accordance with a feature of this embodiment of the invention,the first and second sections 962 and 964 of the retainer device areinterconnected, such that the engagement member 968 is positioned withinthe slotted member 970. The first and second sections 962 and 964 areheated and bonded together. Heating first and second sections 962 and964 softens the material of engagement member 968 and the slotted member970, allowing them to be plastically deformed and bonded together. Thefirst and second sections 962 and 964 can be bonded together usingultrasonic vibratory energy as has previously been described.

[0485] Embodiment of FIGS. 40-47

[0486] Referring to FIGS. 40-47 the suture retainer 1030 is utilized tofixedly interconnect opposite portions 1032 and 1034 of a suture 1036.The portions 1032 and 1034 of the suture 1036 extend in oppositedirections through the retainer 1030. An intermediate portion 1038 ofthe suture extends between the portions 1032 and 1034 and extends aroundbody tissue 1040 to the retainer 1030. It should be understood that thesuture 1036 and retainer 1030 could be connected with each other and/orthe body tissue 1040 in a manner which is different than the specificmanner illustrated in FIG. 40. For example, the portions 1032 and 1034of the suture 1036 may extend in the same direction from the retainer1030.

[0487] It is contemplated that the suture 1036 and retainer 1030 may beutilized to secure body tissue 1040 in many different ways. For example,the suture 1036 and retainer 1030 may be utilized to secure one piece ofbody tissue to another piece of body tissue. The suture 1036 andretainer 1030 may be utilized to secure soft body tissue to hard bodytissue (bone). The suture 1036 and retainer 1030 may be utilized toconnect hard body tissue to hard body tissue in the manner disclosed inU.S. Pat. No. 6,238,395. The suture 1036 and retainer 1030 may bedisposed entirely within a patient's body or may engage a surface areaon the patient's body.

[0488] It is contemplated that the suture 1036 can be constructed of asingle filament or of a plurality of filaments. The suture 1036 may beformed of biodegradable or nonbiodegradable material. Similarly, theretainer 1030 may be formed of biodegradable or nonbiodegradablematerial.

[0489] The retainer 1030 includes a lower or base section 1046 (FIGS. 41and 42) and an upper or cover section 1048. The portions 1032 and 1034of the suture 1036 extend through passages 1052 and 1054 (FIGS. 41 and46) formed between the upper and lower sections 1046 and 1048 of theretainer 1030. The passages 1052 and 1054 have a cross sectional areawhich is slightly greater than the cross sectional area of the suture1036 (FIG. 46). Therefore, the portions 1032 and 1034 of the suture 1036can be readily pulled through the passages 1052 and 1054 when theretainer 1030 is in the initial or undeformed condition illustrated inFIG. 46. It should be understood that the passages 1052 and 1054 couldhave a configuration other than the configuration illustrated in FIG.46.

[0490] Once the suture 1036 has been tensioned with a desired force, theretainer 1030 is plastically deformed in the manner illustratedschematically in FIG. 47. This results in the portions 1032 and 1034 ofthe suture 1036 being securely gripped between the lower and uppersections 1046 and 1048 of the retainer 1030. The portions 1032 and 1034of the suture 1036 are gripped with a clamping action which holds themagainst movement relative to each other and to the retainer 1030. Thisresults in the desired tension being maintained in the suture 1036.

[0491] The lower section 1046 of the retainer 1030 includes a right (asviewed in FIG. 42) recess 1058 and a left recess 1060. The right andleft recesses 1058 and 1060 have the same configuration and are disposedthe same distance from a central axis of the circular lower section 1046of the retainer 1030. Although the recesses 1058 and 1060 could havemany different configurations, the illustrated recesses have elongatedconfigurations with parallel longitudinal central axes which extendperpendicular to the central axis of the circular lower section 1046.

[0492] The upper section 1048 has a circular body 1064 from which right(as viewed in FIG. 42) and left projections 1066 and 1068 extend. Theright and left projections 1066 and 1068 have the same cross sectionalconfiguration which corresponds to the cross sectional configuration ofthe recesses 1058 and 1060 (FIGS. 43-46). The projections 1066 and 1068have an elongated configuration with parallel longitudinal central axeswhich extend perpendicular the central axis of the circular body 1064 ofthe upper section 1048 of the retainer 1030. The projections 1066 and1068 are disposed the same distance from a central axis of the uppersection 1048. It is contemplated that the projections 1066 and 1068could have a configuration which is different than the specificconfiguration illustrated in FIGS. 43-46.

[0493] A center projection 1072 is disposed on the lower section 1046 ofthe retainer 1030 at a location midway between the right and leftrecesses 1058 and 1060 (FIGS. 42, 43 and 46). The left and rightprojections 1066 and 1068 on the upper section 1048 of the retainer 1030are telescopically received in the right and left recesses 1058 and 1060in the lower section 1046 of the retainer 1030 (FIGS. 41, 42, and 46).This results in the upper section 1038 of the retainer being positionedin a coaxial relationship with the lower section 1036 of the retainer.The center projection 1072 is disposed midway between the right and leftprojections 1066 and 1068 when they engage the right and left recesses1058 and 1060. The right and left recesses 1058 and 1060 cooperate withthe right and left projections 1066 and 1068 to orient the upper sectionof the retainer 1048 with the longitudinal axes of the right and leftprojections 1066 and 1068 extending parallel to the longitudinal axis ofthe center section 1072.

[0494] When the right and left projections 1066 and 1068 are disposed inthe right and left recesses 1058 and 1060 (FIG. 46), the centerprojection 1072 cooperates with the right and left projections topartially form the passages 1052 and 1054. The bottom (as viewed in FIG.46) of the passage 1052 is formed by a gripper surface area 1078. Thebottom of the passage 1054 is formed by a gripper surface area 1080.

[0495] The gripper surface areas 1078 and 1080 on the lower section 1046face and are parallel to gripper surface areas 1082 and 1084 (FIG. 46)on the upper section 1048. The gripper surface areas 1078, 1080, 1082and 1084 cooperate with the projections 1066, 1068 and 1072 to definethe parallel passages 1052 and 1054. The gripper surface areas 1078,1080, 1082 and 1084 may be roughened or knurled to enhance their abilityto grip the suture 1036.

[0496] The right and left projections 1066 and 1068 have flat parallellongitudinally extending inner side surfaces 1088 and 1090 (FIGS. 43 and46). The inner side surfaces 1088 and 1090 on the projections 1066 and1068 extend perpendicular to the gripper surface areas 1082 and 1084 onthe circular body 1064 of the upper section 1048 of the retainer 1030.In addition, the right and left projections 1068 and 1070 have outerside surfaces 1092 and 1094 which extend parallel to the inner sidesurfaces 1088 and 1090.

[0497] The center projection 1072 has parallel right and left sidesurfaces 1096 and 1098 which extend perpendicular to the gripper surfaceareas 1078 and 1080 on the lower section 1046 (FIG. 43). When the rightand left projections 1066 and 1068 on the circular body 1064 of theupper section 1048 of the retainer 1030 are disposed in the right andleft recesses 1058 and 1060 on the lower section 1046 (FIG. 46), theright and left side surfaces 1096 and 1098 on the center projection 1072extend parallel to the inner side surfaces 1088 and 1090 on the rightand left projections 1066 and 1068.

[0498] The passages 1052 and 1054 through the retainer 1030 are formedby flat surfaces on the lower and upper sections 1046 and 1048 of theretainer. The flat side surfaces which form the parallel passages 1052and 1054 are effective to guide a leading end of a portion of a suture1036 as the suture is inserted into the passage. Thus, the leading endof the portion 1032 of the suture is directed by the side surfaces 1078,1088, 1082, and 1098 (FIG. 46) formed on the lower section 1046, rightprojection 1066, body 1064 and center projection 1072 respectively.Similarly, the leading end of the portion 1034 of the suture 1036 isdirected by the side surfaces 1080, 1090, 1084 and 1096 formed on thelower section 1046, left projection 1068, body 1064 and centerprojection 1072. By forming the passages 1052 and 1054 with elongatedside surfaces, insertion of the portions 1032 and 1034 of the suture1036 into the passages is facilitated. This is because once a portion1032 or 1034 of the suture 1036 has been inserted into one of thepassages 1052 or 1054, the side surfaces of the passage maintain theleading end of the suture in a desired relationship with the passage asthe suture continues to be moved into the passage.

[0499] The center projection 1072 is effective to position the portions1032 and 1034 of the suture 1036 so that they are disposed on oppositesides of and equal distances from a central axis of the retainer 1030.This results in off setting movements being applied to the retainer 1030by forces transmitted to the retainer from the portions 1032 and 1034 ofthe suture 1036. Therefore, there is little or no tendency for theretainer 1030 to rotate or flip relative to the body tissue 1040.

[0500] The right and left projections 1066 and 1068 on the upper section1048 of the retainer 1030 are disposed in the recesses 1058 and 1060 inthe lower section 1046 of the retainer 1078 (FIG. 46) during insertionof the portions 1032 and 1034 of the suture 1036 into the passages 1052and 1054 in the retainer 1030. To hold the projections 1066 and 1068 inthe recesses 1058 and 1060, there is an interference fit between theprojections and the recesses. Thus, the distance between an outer sidesurface 1102 of the right recess 1058 (FIG. 56) and an inner sidesurface 1104 of the right recess is slightly less than the distancebetween the outer side surface 1092 and inner side surface 1088 on theright projection 1066. The resulting interference between the rightprojection 1066 and the right recess 1058 is effective to hold the rightprojection in the right recess.

[0501] Similarly, the left recess 1060 has parallel outer and inner sidesurfaces 1110 and 1112. The outer and inner side surfaces 1110 and 1112of the left recess 1060 are spaced apart by distance which is slightlyless than the distance between the outer side surface 1094 and innerside surface 1090 on the left projection 1068. When the left projection1068 is pressed into the left recess 1060, the resulting interferencebetween the side surfaces 1090 and 1094 on the projection 1068 and theside surfaces 1110 and 1112 on the recess 1060 hold the left projectionin the left recess. The side surfaces 1102, 1104, 1110 and 1112 on therecesses 1058 and 1060 extend parallel to the side surfaces 1096 and1098 on the center projection 1072 and perpendicular to the grippersurface areas 1078 and 1080 on the lower section 1046.

[0502] The interference fit between the projections 1066 and 1068 on theupper section 1048 of the retainer with the recesses 1058 and 1060 inthe lower section 1046 of the retainer holds the two sections of theretainer against movement relative to each other during insertion of theportions 1032 and 1034 of the suture 1036 into the passages 1052 and1054. However, it is contemplated that the upper section 1048 and lowersection 1046 of the retainer 1030 may be held against movement relativeto each other by means other than an interference fit. For example,latch surfaces on the projections 1066 and 1068 may engage latchsurfaces formed on the sides of the recesses 1058 and 1060. These latchsurfaces may have a generally wedge shaped configuration. Alternatively,a pin may extend through at least a portion of the lower section 1046 ofthe retainer and the projections 1066 and 1068 on the upper section 1048of the retainer to hold the upper section against movement relative tothe lower section.

[0503] The lower section 1046 and upper section 1048 of the retainer1030 are formed as two separate pieces. However, it is contemplated thatthe lower and upper sections 1046 and 1048 of the retainer 1030 could beformed as one piece. If this is done, relatively weak connectors may beprovided between the projections 1066 and 1068 and the base section 1046to hold the base and upper sections 1046 and 1048 in a desired spatialrelationship with each other during insertion of the portions 1032 and1034 of the suture 1036 into the passages 1052 and 1054. The weakconnectors may be broken to enable the portions 1032 and 1034 of thesuture 1036 to be gripped between the retainer sections 1046 and 1048.Alternatively, a flexible strap may be formed between the base section1046 and upper section 1048. By deflecting the strap, the projections1066 and 1068 maybe inserted into the recesses 1058 and 1060.

[0504] When the right and left projections 1066 and 1068 aretelescopically inserted into the right recess 1058 and left recess 1060,the leading or lower (as viewed in FIG. 46) end portions of theprojections engage flat bottom surfaces 1118 and 1120 of the recesses1058 and 1060 (FIG. 56). The flat bottom surfaces 1118 and 1120 extendparallel to the gripper surface areas 1078 and 1080 on the lower section1046 and perpendicular to the side surfaces 1102, 1104, 1110 and 1112 ofthe recesses 1058 and 1060. Engagement of end portions 1124 and 1126 ofthe projections 1066 and 1068 with the bottom surfaces 1118 and 1120 ofthe recesses 1058 and 1060 positions the lower and upper sections 1046and 1048 of the retainer relative to each other and determines the sizeof the passages 1052 and 1054. This results in the passages 1052 and1054 being sized so as to have a cross sectional area which is slightlygreater than the cross sectional area of the portions 1032 and 1034 ofthe suture 1036 to enable the suture to be readily inserted into thepassages.

[0505] The center projection 1072 has a flat upper side surface 1130which extends parallel to the gripper surfaces 1078, 1080, 1082 and1084. The upper side surface 1130 on the center projection 1072 isspaced from the upper section 1048 when the end portions 1124 and 1126of the projections 1066 and 1068 are in engagement with the bottomsurfaces 1118 and 1120 of the recesses 1058 and 1060. However, ifdesired, the center projection 1072 may be disposed in engagement withthe upper section 1048 when the end portions 1124 and 1126 of theprojections 1066 and 1068 are in engagement with the bottom surfaces1118 and 1120 of the recesses 1058 and 1060.

[0506] When the end portions 1124 and 1126 of the projections 1066 and1068 are in engagement with the bottom surfaces 1118 and 1120 of therecesses 1058 and 1060, the portions 1032 and 1034 of the suture 106 canbe freely moved in the passages 1052 and 1054 to enable the retainer1060 to be slid along the suture 1036 to a desired position relative tothe body tissue 1040. The retainer 1030 may be slid along the suture1036 under the influence of force manually applied against the retaineror under the influence of force applied against the retainer by asurgical instrument, such as forceps. As this occurs, the intermediateportion 1038 (FIG. 40) of the suture is tightened around the body tissuewith a desired force.

[0507] Once the retainer 1030 has been positioned in a desired locationrelative to the body tissue 1040 and the suture 1036 tensioned with apredetermined force, the retainer is plastically deformed from theinitial condition illustrated in FIG. 46 to the condition illustrated inFIG. 47. Plastic deformation of the retainer 1030 results in the size ofthe passages 1052 and 1054 being decreased. In addition, the upper side1130 on the center projection 1072 moves into engagement with the uppersection 1048 of the retainer 1030. Engagement of the center projection1072 with the upper section 1048 of the retainer 1030 tends to limit theextent to which the lower and upper section 1046 and 1048 of theretainer are pressed together to thereby limit plastic deformation ofthe retainer 1030.

[0508] If the retainer 1030 is constructed so that the center projection1072 engages the upper section 1048 of the retainer when the endportions 1124 and 1126 of the projections 1066 and 1068 are inengagement with the bottom surface areas 1118 and 1120 of the recesses1058 and 1060, the center projection would also be deformed when theretainer is plastically deformed from the initial condition of FIG. 46to the condition of FIG. 47. With this construction of the retainer1030, the center projection 1072 would be deformed to the same extent asthe projections 1066 and 1068. Therefore, the center projection 1072 maybe formed with an upper end portion which has the same configuration asthe lower end portions 1124 and 1126 of the projections 1066 and 10168.

[0509] To plastically deform and interconnect the lower and uppersections 1046 and 1048 of the retainer 1030, a member 1140 (FIG. 47) ismoved into a groove 1142 in the lower section 1046. The member 1140 actsas an anvil to hold the lower section 1048 during welding. The member1040 is shown as a bar, it is also contemplated that the member 1040 canbe a flat plate for engaging the flat outside surface of the lowersection 1046, wherein the plate can include a lip around its peripheraledge to prevent the lower section 1046 from moving during welding.

[0510] In addition, a second member 1144 engages a flat outer sidesurface 1146 on the upper section 1048 of the retainer 1030. The lowerand upper sections 1046 and 1048 of the retainer 1030 are firmly pressedtogether by force transmitted between the members 1140 and 1144 throughthe retainer. While the lower and upper sections 1046 and 1048 of theretainer 1030 are gripped between the members 1140 and 1144 with aclamping action, energy is transmitted from the member 1144 to theretainer 1030.

[0511] The energy applied to the retainer 1030 is effective to heat theend portions 1124 and 1126 of the projections 1066 and 1068 into atransition temperature range for the polymeric material of theprojections. Force applied against the retainer 1030 by the members 1140and 1144 (FIG. 47) causes the heat softened material of the projections1066 and 1068 to flow in the recesses 1058 and 1060. To a lesser extent,material of the lower section 1046 is heated and also flows in therecesses 1058 and 1060.

[0512] As this occurs, the heated material of the projections 1066 and1068 may be forced upward toward the portions 1032 and 1034 of thesuture 1036. The heated material tends to bond to the portions 1032 and1034 of the suture 1036. It should be understood that the extent ofdeformation and flow of the heat softened material of the projections1066 and 1068 may be and probably will be greater than the extentillustrated schematically in FIG. 47.

[0513] If the retainer 1030 is constructed so that the center projection1072 is deformed to the same extent as the projections 1066 and 1068,heat softened material of the center projection would flow into thepassages 1052 and 1054. If the upper section 1048 of the retainer 1030has the construction shown in FIG. 43, the upper end portion of thecenter projection would engage the flat lower side surface of the body1064. However, the upper section 1048 of the retainer 1030 may be formedwith a recess to receive the upper end portion of the center projection1072. This recess may have the same configuration as the recesses 1058and 1060 in the lower section 1046 of the retainer 1030.

[0514] If desired, the retainer 1030 may be constructed with the centerprojection 1072 extending from the upper section 1048 of the retainer.If this is done, the center projection 1072 from the upper section 1048of the retainer may have the same configuration as the illustratedconfiguration of the center projection in FIGS. 43 and 44. A recess maybe provided in the lower section 1046 to receive a portion of a centerprojection from the upper section 1048 of the retainer 1030.

[0515] As the heated material of the projections 1066 and 1068 is causedto flow in the recess 1058 and 1060, the size of the passages 1052 and1054 is decreased. This results in the portions 1032 and 1034 of thesuture 1036 being firmly clamped between the gripper surface areas 1078and 1080 on the lower section 1046 and the gripper surface areas 1082and 1084 on the upper section 1048 of the retainer 1030. The forceapplied to the portions 1032 and 1034 of the suture 1036 by the grippersurface areas 1078, 1080, 1082 and 1084 on the lower and upper sections1046 and 1048 of the retainer 1030 is effective to deform the suturefrom the circular cross sectional configuration illustrated in FIG. 46to a generally oval cross sectional configuration illustratedschematically in FIG. 47. Although the illustrated suture 1036 is amonofilament, it is contemplated that the suture could be formed by aplurality of filaments which are braided or twisted together.

[0516] The energy which is applied to the retainer 1030 by the member1144 may be thermal energy, vibratory energy, or light energy. Theenergy may be transmitted by radio frequency waves, ultrasonic waves,heat waves, or light waves. The energy may be vibratory ultrasonic,light, heat, or radio frequency energy. Rather than positioning themember 1140 in the groove 1142 in the lower section 1046 of the retainer1030, the groove 1142 may be omitted and a flat member, similar to themember 1144, may be pressed against the lower section 1046 of theretainer 1030. Energy may be transmitted to the retainer through eitherthe member 1140 or the member 1144 or both of the members 1140 and 1144.

[0517] In the embodiment of the invention illustrated in FIG. 47, theportions 1032 and 1034 of the suture 1036 are clamped between the lowersection 1046 and upper section 1048 of the retainer 1030. The clampingforce applied against the portions 1032 and 1034 of the suture 1036 bythe retainer 1030, holds the retainer and the portions of the sutureagainst relative movement. This results in the suture 1036 and retainer1030 being securely interconnected.

[0518] There is some bonding of material of the retainer to the portions1032 and 1034 of the suture 1036 to further interconnect suture and theretainer. However, the amount of force and energy transmitted from themember 1140 or both of the members 1140 and 1144 to the retainer 1030 issufficient to effect a plastic deformation of the material of theretainer without excessive plastic deformation of the material of thesuture 1036. By avoiding excessive deformation of the material of thesuture 1036, weakening of the suture is avoided. Thus, once the plasticdeformation of the retainer 1030 has been effected by the transmissionof force and energy to the retainer, the lower and upper sections 1046and 1048 of the retainer are fixedly interconnected with the suture 1036without significantly weakening of the suture.

[0519] The end portions 1124 and 1126 of the projections 1066 and 1068have a pointed configuration. Thus, the end portion 1024 of theprojection 1066 includes a flat side surface area 1150 which intersectsa flat side surface area 1152 at a linear point or peak. Therefore,there is line contact between the end portion 1124 of the rightprojection 1066 and the flat bottom surface 1118 of the right recess1058. Similarly, the end portion 1126 of the left projection 1168 has aflat side surface 1156 which intersects a flat side surface 1158 at alinear point or peak on the end portion 1126 of the left projection1068. This results in line contact between the pointed end portion ofthe left projection 1068 and the flat bottom surface 1120 of the leftrecess 1060. However, the end portions 1124 and 1126 of the projections1066 and 1068 may have a conical configuration if desired.

[0520] By forming the end portions 1124 and 1126 of the right and leftprojections 1066 and 1068 with a pointed configuration, the end portionsof the projections are effective to function as energy directors forultrasonic vibratory energy. The pointed end portions 1124 and 1026 ofthe right and left projections 1066 and 1068 are effective to directultrasonic vibratory energy transmitted from the member 1144 to the endsof the projections and to the bottom surfaces 1118 and 1120 of therecesses 1058 and 1060. The pointed configuration of the end portions1124 and 1126 of the projections 1066 and 1068 concentrates the energyand facilitates melting of the material of the projections. To a lesserextent, the material of the lower section 1046 of the retainer 1030 ismelted adjacent to the bottom surfaces 1118 and 1120. This results in asecure bonding and interconnection between the lower and upper sections1046 and 1048 of the retainer 1030.

[0521] Referring to FIG. 29, the suture retainer illustrated in FIGS.40-47 includes substantially flat edges 730, having a non-circular crosssection when viewed from the top or the bottom surface. Additionally,the top or bottom surface can include a convex or concave surface.

[0522] Although generally shown as using ultrasonic energy, it isunderstood that in other embodiments the types of energy or combinationof energies can be utilized to heat the suture retainer, suture, andretainer device. These types of energy or combination of energies caninclude, but not be limited to, radio frequency (RF) energy, laserenergy, infrared energy, microwave energy, ultrasound energy, andcontact heating energy.

[0523] It is contemplated that the viable cells may be incorporated orpositioned on the suture retainer of the present invention. The viablecells may be any desired type of viable cells. It is contemplated thatthe viable cells may correspond to cells which were in a damaged organor other portion of a patient's body. More than one type of viable cellmay be positioned on the suture retainer.

[0524] When the suture retainer is to be positioned in an organ, it iscontemplated that the viable cells on the suture retainer will havecharacteristics associated with the characteristics of normal cells inthe organ in which the support structure is to be positioned. Manyorgans contain cells which have different characteristics and performdifferent functions within the organ. It is contemplated that the viablecells on the suture retainer may have different characteristicscorresponding to the different characteristics of cells of an organ.When the suture retainer is to be positioned outside of an organ, thecells positioned on the support structure may have any desiredcharacteristic or combination of characteristics.

[0525] It is also contemplated that the viable cells can be pluripotentcells that are directed to differentiate into the desired cell type ortypes. One example of such cells is stem cells. The differentiation canbe controlled by applying or exposing the cells to certain environmentalconditions such as mechanical forces (static or dynamic), chemicalstimuli (e.g. pH), and/or electromagnetic stimuli.

[0526] More than one type of cell may be positioned on the sutureretainer. The type of cell positioned at a particular location on thesuture retainer will be determined by the orientation of the supportstructure in a patient's body and by the specific type of tissue desiredat a particular location in a patient's body. For example, stromal cellsmay be positioned at a location where foundation tissue is desired andanother type of cell may be positioned at locations where it is desiredto have tissue perform a special function.

[0527] In order to promote the attachment of the viable cells to thesuture retainer, the suture retainer can be pretreated with an agentthat promotes cell adhesion. One such agent is an organic substancebased on a biofilm. A biofilm is a slimy, glue-like substance that formswhen bacteria attach to surfaces exposed to water. Typically, coloniesof biofilm bacteria are unwanted as they carry out a variety ofdetrimental reactions. However, a sterile biofilm may be used to promoteinitial attachment of cells to the suture retainer.

[0528] The sterile biofilm could be engineered to isolate the glue-likesubstance while eliminating the adverse properties of the bacteria. Theresulting sterile glue-like substance would be used to help the cellsstick to the suture retainer. The engineered biofilm could be added tothe suture retainer in the laboratory that produces the suture retaineror just prior to the addition of the cells by the user. Alternatively,the biofilm and suture retainer could be combined intracorporally.

[0529] This biofilm also could be used as an independent polysaccharidebased adhesive with mild to moderate adhesion forces. The biofilm couldserve as a surgical adhesion or grouting for cells, for tissue fixation(soft tissue to soft tissue, soft tissue to bone, etc.) and as asealant.

[0530] Additionally, it is contemplated that pharmaceutical agents suchas tissue inductive growth factors, additives, and/or other therapeuticagents may be provided on or incorporated into the suture retainer ofthe present invention. Such additives may include materials such asplasticizers, citrate esters, hexametholsebacate, antibiotics (e.g.,tetracyclines, penicillins, mefronidazole, clindamycin, etc.), toprevent infection, etc., or to accomplish other desired conditions orresults, including for example, tissue inductive growth factors topromote a growth of tissue. Addition additives or therapeutic agentsinclude osteoinductive, biocidal, or anti-infection substances. Suitableosteoinductive substances include, for example, growth factors. Thegrowth factors may be selected from the group of IGF (insulin-likegrowth factors), TGF (transforming growth factors), FGB (fibroblastgrowth factors), EGF (epidermal growth factors), BMP (bone morphogenicproteins), and PDGF (platelet-derived growth factors).

[0531] The inductive growth factors, additives, and/or other therapeuticagents may be provided on or incorporated into the suture retainer priorto connection to the suture. Alternatively, the inductive growthfactors, additives, and/or other therapeutic agents may be provided onor incorporated after connection to the suture.

[0532] Embodiment of FIG. 48-55

[0533] Referring to FIGS. 48-51, the ultrasonic energy applicationapparatus 640 of FIG. 25 includes a rigid energy transmission member1170 and a rigid tubular force transmitting member 1172 extends aroundand is coaxial with the cylindrical energy transmission member 1170. Abiasing assembly 1174 continuously urges the force transmitting member1172 toward the left (as viewed in FIG. 48) with a constantpredetermined force. The illustrated embodiment of the biasing assembly1174 includes a helical spring 1176 which is disposed between an annularflange 1178 on a reaction member 1180 and an annular piston 1182. Theannular piston 1182 is fixedly connected to a housing 1184. The housing1184 is connected to the tubular force transmitting member 1172. Thereaction member 1180 is fixedly connected to a manually engagable handle1186.

[0534] A trigger 1188 is pivotally connected with the handle 1186. Thetrigger 1188 is manually pivotal in a clockwise direction (as viewed inFIGS. 48 and 50). Clockwise pivotal movement of the trigger 1188transmits force through a yoke 1190. The force transmitted through theyoke 1190 moves the housing 1184 toward the right (as viewed in FIGS. 48and 50). This rightward movement of the housing 1184 moves a flange 1192on the right (as viewed in FIGS. 48 and 51) or distal end of the tubularforce transmitting member 1172 away from a circular end surface 1194 onthe energy transmission member 1170. The flange 1192 is shown as bar, itis also contemplated that the member 1040 can be a flat plate forengaging the flat outside surface of the suture retainer, wherein theplate can include a lip around its peripheral edge to prevent themovement of the suture retainer during welding.

[0535] The rightward (as viewed in FIGS. 48 and 51) movement of theforce transmitting member 1172 relative to the energy transmissionmember 1170 increases space between the flange 1192 and end surface 1194on the energy transmission member 1172. Increasing the space between theflange 1192 and the end surface 1194 enables the retainer to bepositioned between the flange 1192 and the end surface 1194.

[0536] Once the retainer has been positioned in the space between theflange 1192 and the end surface 1194 on the energy transmission member1170 (FIGS. 48 and 51), the trigger 1188 is released. When the trigger1188 is released, the biasing spring 1176 is effected to urge thehousing 1184 toward the left (as viewed in FIGS. 48 and 50). Theleftward force applied by the spring 1176 against the housing 1184 istransmitted through the force transmitting member 1172 and flange 1192to the retainer. This results in the retainer being clamped between theflange 1192 on the force transmitting member 1172 and end surface 1194on the energy transmission member 1170. The spring 1176 is effective toapply a constant predetermined biasing force to the piston ring 1182.This constant biasing force is transmitted through the housing 1184 andforce transmitting member 1172 to the retainer.

[0537] While the retainer is gripped with a predetermined constant forceby the applicator assembly 640, the retainer is moved to a desiredposition relative to the body tissue. To position the retainer relativeto the body tissue, the surgeon holds the handle 1186 of the applicatorassembly 640 in one hand and tensions the suture with the other hand.The surgeon then manually applies force against the handle 1186 to slidethe retainer along the tensioned suture toward the body tissue. Therelatively long force transmitting member 1172 and energy transmittingmember 1170 enable the applicator assembly 640 to move the retainerthrough a small incision to a remote location in a patient's body as theretainer slides along the suture.

[0538] During performance of a surgical procedure, the suture may bemoved through a cannula to a location disposed within a patient's body.The suture is then positioned relative to the tissue at the remotelocation in the patient's body. However, it should be understood thatthe cannula may be omitted and the suture moved through an openincision.

[0539] Once the suture has been moved to the desired location relativeto the tissue in the patient's body, the suture may be positioned in theretainer while the retainer is disposed outside of the patient's body.Once the suture has been positioned in the retainer, the retainer isgripped by the applicator assembly 640. The flange 1192 on the forcetransmitting member 1172 and end surface 1194 on the energy transmissionmember 1170 of the applicator assembly 640 are effective to apply apredetermined constant force against opposite sides of the retainer tosecurely grip the retainer with the applicator assembly 640.

[0540] While the retainer is gripped by the applicator assembly 640, thesuture is manually tensioned and the retainer is slid along the suturetoward the body tissue. As the retainer is slid along the suture towardthe body tissue, the applicator assembly 640 moves the retainer into thepatient's body. As the retainer is moved into the patient's body, it isgripped with a constant predetermined force by the applicator assembly640.

[0541] Alternatively, the retainer may be gripped by the applicatorassembly 640 outside of the patient's body prior to positioning of thesuture with the retainer. The suture may then be positioned in theretainer while the retainer is gripped by the applicator assembly 640.If desired, positioning of the suture in the retainer may be performedwith the retainer inside the patient's body.

[0542] If the applicator assembly 640 is utilized to move the retainerthrough a cannula into the patient's body before the suture ispositioned the retainer, suitable instruments may be utilized to gripthe suture in the patient's body and to move the suture through theretainer. The instruments which engage the suture and move it throughthe retainer while the retainer is gripped by the applicator assembly640, may extend through the cannula along with the applicator assembly.Alternatively, the instruments which move the suture through theretainer may be moved into the patient's body through a cannula spacedfrom the cannula through which the applicator assembly 640 moves theretainer into the patient's body. In order to minimize incisions in thepatient's body, it may be preferred to utilize a single cannula toaccommodate movement of the applicator assembly 1640, retainer, suturepositioning instruments, and the suture into the patient's body.

[0543] Once the retainer has been positioned in a desired relationshipwith body tissue and the suture, the suture is pulled with apredetermined force. This results in a predetermined tension beingestablished in the suture. While the predetermined tension is maintainedin the suture, the retainer is connected to suture, holding the sutureagainst movement relative to the retainer. To effect plastic deformationof the retainer and connection of the retainer with the suture, energyis transmitted from an energy source 1196 (FIG. 48) through the energytransmission member 1170 to the retainer. At this time, the retainer isclamped between the flange 1192 on the force transmitting member 1172and the end surface 1194 on the energy transmission member 1170.

[0544] In the illustrated embodiment of the applicator assembly 640, theenergy source 1196 is a source of ultrasonic vibratory energy at afrequency above that which can normally be detected by the human ear,that is about 16 to 20 kilohertz. Although there are a wide range offrequencies which may be utilized, it is believed that it may bedesirable to use ultrasonic energy having a frequency of between 20kilohertz and 70 kilohertz. It is believed that it may be desired to useultrasonic vibratory energy of a frequency between 39.5 and 41kilohertz. When an actuated switch 1198 (FIG. 48) is closed, ultrasonicvibratory energy is transmitted through the energy transmission member1170 to the retainer. The ultrasonic vibratory energy creates frictionalheat which is effective to heat material of the retainer into itstransition temperature range while the material of the suture remains ata temperature below its transition temperature range. The actuatedswitch 1198 can be external to the applicator assembly 640, for example,a foot peddle, or incorporated into the applicator assembly 640, forexample a bottom of trigger.

[0545] However, it should be understood that even the entire transitiontemperature range for the suture could be co-extensive with thetransition temperature range for the retainer. In fact, the transitiontemperature range of the suture could extend below the transitiontemperature range of the retainer. However, it is believed that it maybe preferred to have the transition temperature range for the sutureabove at least a portion of the transition temperature range of theretainer.

[0546] Although one specific preferred embodiment of the applicatorassembly 640 has been illustrated in FIGS. 49-51, it is contemplatedthat the applicator assembly could have a different construction and/ormode of operation. For example, the applicator assembly 640 may have anyone of the constructions and mode of operations disclosed in U.S. Pat.No. 6,585,750, the contents of which are incorporated herein byreference.

[0547] The leading end portion of the force transmitting member 1172(FIG. 51) extends part way around the end surface 1194 on the energytransmission member 1170. This results in the formation of a shield 1200which extends part way around the retainer when the retainer is clampedbetween the flange 1192 and the end surface 1194 on the energytransmission member 1170. The shield 1200 has an inner side surface 1202which forms a portion of a cylinder. The side surface 1202 engages theperiphery of the retainer to position the retainer relative to theenergy transmission member 1170 in a direction transverse to alongitudinal central axis of the energy transmission member.

[0548] The shield 1200 is effective to at least partially blockengagement of body tissue with the retainer as the retainer ispositioned in a patient's body and as energy is transmitted to theretainer from the energy transmission member 1170. It is contemplatedthat the shield 1200 could be constructed in such a manner as to extendcompletely around the retainer. This would allow use of the applicatorassembly 640 in a moist environment or in an aqueous environment inwhich the retainer is completely or almost completely submerged inliquid.

[0549] The force transmitting member 1172 has a flange 1192 whichengages the retainer. However, it is contemplated that the flange 1192could be eliminated and a circular end plate provided at the distal endof the force transmitting member 1172. The use of a plate would providefor a wider area of engagement of the force transmitting member 1172with the retainer.

[0550] Referring to FIGS. 52-55, the ultrasonic energy applicationapparatus 640 has been provided with an elongated, tubular sleeve member1204 defining a passage therethrough, wherein the sleeve member 1204 isslidable over the force transmitting member 1172. The sleeve member 1204includes a proximal end and a distal end, wherein the proximal endincludes a channel 1206 for engaging a pin 1208 positioned on the forcetransmitting member 1172. The channel 1206 and pin 1208 cooperate tolimit the range of motion of the sleeve member 1204 over the forcetransmitting member 1172. In a first position, the distal end of thesleeve member 1204 is positioned to provide access to the gap betweenthe end surface 1194 on the energy transmission member 1170 and theflange 1192 connected with the force transmitting member 1172, forinsertion and removal of the suture retainer. In a second position, thedistal end of the sleeve member 1204 covers the gap between the endsurface 1194 on the energy transmission member 1170 and the flange 1192connected with the force transmitting member 1172 for the application ofultrasonic energy. The sleeve member 1204 acts to protect the suture andadjacent tissue from the ultrasonic energy by shielding them from theultrasonic energy while in the second position.

[0551] The proximal end of the sleeve member 1204 further includes acollar member 1210 having at least one notch 1212 configured to receivethe suture. The collar member 1210 maintains the tension on the suture.For example, in a method of use the sleeve member 1204 is manually slidinto the first position, providing access to the gap between the endsurface 1194 on the energy transmission member 1170 and the flange 1192connected with the force transmitting member 1172. The suture 1214 isthen positioned in relation to the suture retainer 1216 and the suture1214 and the retainer 1216 are positioned in the gap between the endsurface 1194 on the energy transmission member 1170 and the flange 1192connected with the force transmitting member 1172, where the suture 1214and retainer 1216 are disposed between the end surface 1194 and theflange 1192. The suture leads 1218 a position in the collar membernotches 1212, tensioning the suture 1214. The trigger 1188 is released,such that the biasing spring 1178 is effected to urge the housing 1184to the left (as viewed in FIGS. 48 and 50). The force applied by thehousing 1184 is transmitted through the force transmitting member 1172and flange 1192 to the retainer 1216. The sleeve member 1204 is moved tothe second position, wherein the distal end of the sleeve member 1204covers the gap between the end surface 1194 on the energy transmissionmember 1170 and the flange 1192 connected with the force transmittingmember 1172. In the second position, the sleeve member 1204 forces thesuture 1214 away from the end surface 1194 of the energy transmissionmember 1170. The non-engaged portion of the suture 1214 is positionedalong the outer surface of the sleeve member 1204 and engages the notch1212 in the collar member 1210. The ultrasonic energy is provided to theend surface 1194 of the energy transmission member 1170, securing theretainer 1216 to the suture 1214.

[0552] To remove the coupled suture 1214 and suture retainer 1216, thesleeve member 1204 is moved to the first position, providing access tothe gap between the end surface 1194 on the energy transmission member1170 and the flange 1192 connected with the force transmitting member1172. The trigger 1118 is positioned to move the housing 1184 to theright (as viewed in FIGS. 48 and 50). The rightward movement of thehousing 1184 separates the force transmitting member 1172 and flange1192 to the retainer 1216. The suture 1214 and retainer 1216 are removedfrom the gap between the end surface 1194 on the energy transmissionmember 1170 and the flange 1192 connected with the force transmittingmember 1172.

[0553] It is further contemplated that the sleeve member 1204 includes abias member, wherein the bias member biases the sleeve member into thesecond position. The sleeve member 1204 is manually slid into the firstposition, providing access to the gap between the end surface 1194 onthe energy transmission member 1170 and the flange 1192 connected withthe force transmitting member 1172. The suture 1214 is then positionedin relation to the retainer 1216 and the suture 1214 and the retainer1216 are positioned in the gap between the end surface 1194 on theenergy transmission member 1170 and the flange 1192 connected with theforce transmitting member 1172, where the suture 1214 and retainer 1216are disposed between the end surface 1194 and the flange 1192. Thesleeve member 1204 can be held in the first position, for example, bythe pin 1208 engaging a locking notch in the channel 1206.

[0554] Alternatively, the sleeve member 1204 includes a bias member,wherein the bias member biases the sleeve member 1204 into the firstposition, providing access to the gap between the end surface 1194 onthe energy transmission member 1170 and the flange 1192 connected withthe force transmitting member 1172. The suture 1214 is then positionedin relation to the retainer 1216 and the suture 1214 and the retainer1216 are positioned in the gap between the end surface 1194 on theenergy transmission member 1170 and the flange 1192 connected with theforce transmitting member 1172, where the suture 1214 and retainer 1216are disposed between the end surface 1194 and the flange 1192. Thesleeve member 1204 is manually slid into the second position, whereinthe distal end of the sleeve member 1204 covers the gap between the endsurface 1194 on the energy transmission member 1170 and the flange 1192connected with the force transmitting member 1172. The sleeve member1204 can be held in the second position, for example, by the pin 1208engaging a locking notch in the channel 1206.

[0555] In an embodiment, the ultrasonic energy application apparatus 640includes a safety switch. The safety switch is operably connected to thesleeve member 1204 and the force transmitting member 1172, such that thesafety switch can prevent the energy source 1196 from transmittingultrasonic vibratory energy to the energy transmission member 1170 whenthe sleeve member 1204 is in the first position. For example, when thesleeve member 1204 is in the first position, the safety switch isactuated into an “OFF” position, preventing the energy source 1196 fromsupplying ultrasonic vibratory energy to the energy transmission member1170. This places the ultrasonic energy application apparatus 640 in a“SAFE MODE.” When the sleeve member 1204 is moved into the secondposition, the safety switch is actuated into an “ON” position, allowingthe energy source 1196 to transmit ultrasonic vibratory energy to theenergy transmission member 1170. The actuation of the safety switch tothe “ON” position does not initiate the transmission of energy to theenergy transmission member 1170, but instead places the ultrasonicenergy application apparatus 640 in an “ACTIVE MODE,” wherein the energysource 1196 is capable of transmitting energy to the energy transmissionmember 1170.

[0556] Embodiment of FIGS. 56-69

[0557] Referring to FIG. 56, the energy application apparatus 640 ofFIG. 25 includes a handle assembly 1300 and a controller assembly 1302removable attachable thereto. The controller assembly 1302 is slidablypositionable on the handle assembly 1300, providing a substantiallyconstant force to a suture retainer disposed therein.

[0558] Referring to FIGS. 57 and 58, the handle assembly 1300 includes ahandle 1304 having a nose portion 1306 with a groove 1308 there around.An end effector 1310 is connected to the handle 1304, through the noseportion 1306, being operably connected to an energy source. The endeffector 1310 transmits the energy from the energy source to a tip 1312portion of the end effector 1310. The end effector tip portion 1312includes a tip protrusion 1314 for engaging a portion of the sutureretainer.

[0559] A plunger key 1316 is positioned about the end effector 1310,adjacent to the handle nose portion 1306. The end effector 1310 includesflatten side portions 1318 configured for receiving the plunger key1316, thereby preventing the plunger key 1316 from rotating about theend effector 1310. The plunger key 1316 includes a rectangularprotrusion 1320 for engaging and properly aligning the controllerassembly 1302.

[0560] Referring to FIG. 59, the controller assembly 1302 includes atubular section 1322 operably connected to a controller 1324. Thetubular section 1322 is dimensioned to slide over the end effector 1310,such that the end effector tip portion 1312 is substantially positionedin an end portion 1326 of the tubular section 1322. The end portion 1326of the tubular section 1322 is configured to receive a suture retainer,which can thereby prevent movement of the suture retainer within thetubular section 1322. For example, the end portion 1326 of the tubularsection 1322 can include a dove tail configuration 1327 for receiving acorresponding shaped suture retainer (See FIG. 60). The tubular section1322 is effective to at least partially protect the suture and adjacenttissue from the energy transmitted through the end effector 1312 as thesuture retainer is positioned in a patient's body.

[0561] The controller 1324 includes a tension lever 1328 pivotallyconnected thereto. The tension lever 1328 is operatively connected tothe tubular section 1322, such that a substantially constant force isapplied to a suture retainer position in the tubular section 1322between the tubular section end portion 1326 and the end effector tipportion 1312. The operative connection between the tubular section 1322and the tension lever 1328 includes a bias member 1330 for applying thesubstantially constant force to the suture retainer. The tension leverbias member 1330 compresses the suture retainer between the tubularsection end portion 1326 and the end effector tip portion 1312 with acompressive force of about 1 lb. to 20 lbs. This range of compressiveforce has been found to be particularly effective with ultrasonic and orR F energy. However, higher or lower forces can be applied if desired.

[0562] The controller assembly 1302 further includes a latch assembly1332 for connecting the controller assembly 1302 to the handle assembly1300. The latch assembly 1330 include a latch post 1334 rotatablymounted in the controller 1324. The latch post 1334 is substantiallycylindrical in shape, having a radius dimensioned for engaging thegroove 1308 in the handle nose portion 1306. The latch post 1334includes a flattened section 1336, such that when the flattened section1336 is adjacent to the handle nose portion groove 1308 the latch post1334 does not engage the handle nose portion groove 1308, allowing forremoval of the controller assembly 1302 for the handle assembly 1300.(See also FIG. 61). A latch lever 1338 is connected to the latch post1334 for selectively rotating the latch post 1334 for engaging anddisengaging the handle nose portion groove 1308. A bias member 1340 ispositioned about the latch post 1334, biasing the latch post 1334 in anengaging position.

[0563] Referring to FIGS. 61 and 62, the controller assembly 1302 isconnected to the handle assembly 1300 by sliding the end effector 1310through the controller 1324 into the tubular section 1322. Thecontroller assembly 1302 is slid over the handle assembly 1300 until therectangular protrusion 1320 of the plunger key 1316 slibably engages aslotted section 1342 of the controller 1324, aligning the controllerassembly 1300 on the handle assembly 1302. The latch lever 1328 isactuated, positioning the latch post 1334 in a non-engaging position.The controller assembly 1302 is slid over the handle assembly 1300 untilthe latch post 1334 is positioned adjacent to the handle nose portiongroove 1308. The latch lever 1338 is released such that the latch post1334 engages the handle nose portion groove 1308, securing thecontroller assembly 1302 to the handle assembly 1300.

[0564] To load a suture retainer in the energy application apparatus 640of the present invention, the tension lever 1328 is actuated, opening agap between the tubular section end portion 1326 and the end effectortip portion 1312. A suture retainer is positioned between the gapbetween the tubular section end portion 1326 and the end effector tipportion 1312. The tension lever 1328 is released, closing the gap, withthe end effector 1310 pressing against the suture retainer. The tipprotrusion 1314 on the end effector tip portion 1312 will engage anupper section of the suture retainer, capturing the upper section of thesuture retainer. This enables the upper section of the suture retainerto be separated from a lower section of the suture retainer when thetension lever 1328 is actuated.

[0565] When the suture retainer is in the separated position, the energyapplication apparatus 640 securely holds the upper and lower sections ofthe suture retainer, preventing the upper and lower sections from beingdislodged from the energy application apparatus 640 into the body. Theseparation of the upper and lower sections of the suture retaineradvantageously allows the suture to be loaded intra-corporally from thefront into the suture retainer, without the suture having to be threadedthrough the suture retainer. For example, the energy applicationapparatus 640 is positioned in the body, wherein the retainer sectionsare disposed about the suture. The tension lever 1328 is released,closing the upper and lower suture retainer sections about the suture.The suture can be loaded extra-corporally into the suture retainer in asimilar fashion.

[0566] Referring to FIG. 63, tension lever bias member 1330 can be aspring 1346 inside the controller 1324, interposed between tubularsection 1322 and a ring key 1348. The ring key 1348 assists in aligningthe tubular section 1322 with the controller 1324. The tension lever1328 is used to compress the spring 1346, opening the gap between thetubular section end portion 1326 and the end effector tip portion 1312.

[0567] Referring to FIGS. 63 and 64, a suture tensioner 1350 is providedon the tubular section 1322. The suture tensioner 1350 places asubstantially constant tension on a suture lead. The suture tensioner1350 includes a projection 1352 having a pulley portion 1354 and a cleatportion 1356. The suture is threaded about the pulley portion 1354 andpulled downward, being cinched in the cleat portion 1356. The suturetensioner 1350 includes a bias member 1358 allowing the suture tensioner1350 to be displaced about 0.5 inches on the tubular section 1322 andproviding a 2-10 lb. tension to the suture. The bias member 1358 can bea spring 1360 within the suture tensioner 1350, interposed between thesuture tensioner 1350 and a ring key 1362. It is envisioned that one ormore suture tensioners 1350 can be provided on the tubular section 1322.The use of the suture tensioner 1350 to hold the suture, frees up thesurgeon from holding the suture, maintaining the predetermined force onthe suture during the connection of the suture retainer to the suture.

[0568] Referring to FIG. 65, a suture retainer 1364 is utilized tofixedly interconnect opposite portions a suture. Suture retainer 1364,like other suture retainers disclosed herein, and those known in theart, can be used with energy application apparatus 640. The sutureretaining can also be used with other energy applicators. The sutureretainer 1364 includes an upper or cover section 1368 and a lower orbase section 1370. The suture extends through passages 1372 and 1374formed between the upper and lower sections 1368 and 1370 of the sutureretainer 1364. The passages 1372 and 1374 have a cross sectional areawhich is slightly greater than the cross sectional area of the suture.Therefore, portions of the suture can be readily pulled through thepassages 1372 and 1374 when the suture retainer 1364 is in the initialor undeformed condition illustrated. It should be understood that thepassages 1372 and 1374 could have a configuration other than theconfiguration illustrated.

[0569] Referring to FIGS. 65 and 66, the upper section 1368 of thesuture retainer 1364 has a rectangular body from which first and secondprojections 1376 and 1378 extend. The first and second projections 1376and 1378 have the same configuration and are disposed the same distancefrom a central axis of the rectangular upper section 1368 of the sutureretainer 1364. Although the first and second projections 1376 and 1378could have many different configurations, the illustrated projections1376 and 1378 have elongated configurations with parallel longitudinalcentral axes which extend perpendicular to the central axis of the uppersection 1368.

[0570] Referring to FIGS. 65 and 67, the lower section 1370 has arectangular body including first and second recesses 1380 and 1382therein. The first and second recesses 1380 and 1382 have the same crosssectional configuration which corresponds to the cross sectionalconfiguration of the first and second projections 1376 and 1378 of theupper section 1368. The first and second recesses 1380 and 1382 have anelongated configuration with parallel longitudinal central axes whichextend perpendicular to the central axis of the rectangular body of thelower section 1370 of the suture retainer 1364. The first and secondrecesses 1380 and 1382 are disposed the same distance from a centralaxis of the lower section 1370. It is contemplated that the first andsecond recesses 1380 and 1382 could have a configuration which isdifferent than the specific configuration illustrated.

[0571] A center projection 1384 is disposed on the lower section 1370 ofthe suture retainer 1364 at a location midway between the first andsecond recesses 1380 and 1382. The first and second projections 1376 and1378 on the upper section 1368 of the suture retainer 1364 aretelescopically received in the first and second recesses 1380 and 1382in the lower section 1370 of the suture retainer 1364. This results inthe lower section 1370 being positioned in a coaxial relationship withthe upper section 1368 of the suture 1364. The center projection 1384 isdisposed midway between the first and second projections 1376 and 1378when they engage the first and second recesses 1380 and 1382. The firstand second recesses 1380 and 1382 cooperate with the first and secondprojections 1376 and 1378 to orient the upper section 1368 with thelongitudinal axes of the first and second projections 1376 and 1378extending parallel to the longitudinal axis of the center section 1384.

[0572] When the first and second projections 1376 and 1378 are disposedin the first and second recesses 1380 and 1382, the center projection1384 cooperates with the first and second projections 1376 and 1378forming the passages 1372 and 1374. The passages 1372 and 1374 areeffective to guide a leading end of a portion of a suture as the sutureis inserted into the passages 1372 and 1374.

[0573] The center projection 1384 is effective to position the suture sothat end portions of the suture are disposed on opposite sides of andequal distances from a central axis of the suture retainer 1364. Thisresults in off setting movements being applied to the suture retainer1364 by forces transmitted to the suture retainer 1364 from the suture.Therefore, there is little or no tendency for the suture retainer 1364to rotate or flip relative to the body tissue.

[0574] The first and second projections 1376 and 1378 on the uppersection 1368 of the suture retainer 1364 are disposed in the first andsecond recesses 1380 and 1382 in the lower section 1370 of the sutureretainer 1364 during insertion of the suture into the passages 1372 and1374 in the suture retainer 1364. To hold the projections 1376 and 1378in the recesses 1380 and 1382, there is an interference fit between theprojections 1376 and 1378 and the recesses 1380 and 1382. Thus, thedistance between an outer side surface and an inner side surface of thefirst recess 1380 is slightly less than the distance between and outerside surface and inner side surface on the first projection 1376. Theresulting interference between the first projection 1376 and the firstrecess 1380 is effective to hold the first projection 1376 in the firstrecess 1380.

[0575] Similarly, the second recess 1382 has parallel outer and innerside surfaces which are spaced apart by distance which is slightly lessthan the distance between outer and inner side surfaces on the secondprojection 1378. When the second projection 1378 is pressed into thesecond recess 1382, the resulting interference between the side surfaceson the projection 1378 and the side surfaces on the recess 1382 holdsthe second projection 1378 in the second recess 1382.

[0576] The interference fit between the projections 1376 and 1378 on theupper section 1368 with the recesses 1380 and 1382 in the lower section1370 of the suture retainer 1364 holds the two sections 1368 and 1370 ofthe suture retainer 1364 against movement relative to each other duringinsertion of the suture into the passages 1372 and 1374. However, it iscontemplated that the upper and lower section 1368 and 1370 of thesuture retainer may be held against movement relative to each other bymeans other than an interference fit.

[0577] Referring again to FIG. 65, the upper section 1368 of the sutureretainer 1364 includes a center recess 1386, interposed between thefirst and second projections 1378 and 1380. The center recess 1386 isconfigured to receive the end effector tip portion 1312, such that theend effector tip portion 1312 captures the upper section 1368 of thesuture retainer 1364. The end effector tip portion 1312 capturing of theupper section 1368 facilitates the separation of upper section 1368 fromthe lower section 1370 when the tension lever 1328 is actuated, formingthe gap between the upper and lower section 1368 and 1370 of the sutureretainer 1364 and allowing the suture to be loaded from the front, whichcan be done intra- or extracorporally. Additionally, end effector tipportion 1312 acts to prevent rotational movement of the lower section1370 and upper section 1368 of the suture retainer 1364.

[0578] Referring to FIG. 68, the lower section 1370 of the sutureretainer 1364 is configured to be securely inserted in the tubularsection 1322 of the controller assembly 1302. The end portion 1326 ofthe tubular section 1322 is configured to receive the lower section 1370of the suture retainer, preventing movement of the lower section 1370with respect to the upper section 1368 of the suture retainer 1364 andwithin the tubular section 1322. For example, the side portions 1388 ofthe lower section 1370 can have a dove tailed configuration, dimensionedfor insertion into an oppositely dove tailed configured end portion ofthe tubular section 1326.

[0579] The upper and lower section 1368 and 1370 of the suture retainer1364 are formed as two separate pieces. However, it is contemplated thatthe upper and lower sections 1368 and 1370 of the suture retainer 1364could be formed as one piece. If this is done, relatively weakconnectors may be provided between the projections 1376 and 1378 and thelower section 1370 to hold the upper and lower sections 1368 and 1370 ina desired spatial relationship with each other during insertion of thesuture into the passages 1372 and 1374. The weak connectors may bebroken to enable the suture to be gripped between the suture retainersections 1368 and 1370. Alternatively, a flexible strap may be formedbetween the upper and lower sections 1368 and 1370. By deflecting thestrap, the projections 1376 and 1378 may be inserted into the recesses1380 and 1382.

[0580] Once the suture has been tensioned with a desired force, thesuture retainer 1364 is plastically deformed, resulting in the suturebeing securely gripped between the upper and lower sections 1368 and1370 of the suture retainer 1364. The suture is gripped with a clampingaction which holds the suture against movement relative to the sutureretainer 1364. This results in the desired tension being maintained inthe suture.

[0581] To plastically deform and interconnect the upper and lowersections 1368 and 1370 of the suture retainer 1364, the suture retainer1364 is loaded into the energy application apparatus 640. The sutureretainer 1364 is loaded into the tubular section 1322 such that the endeffector tip portion 1312 captures the upper section 1368 and thetubular section end portion 1326 captures the lower section 1370. (Seealso FIG. 69). After the suture is loaded into the suture retainer 1364,as described above, the tension lever 1328 is released, compressing thesuture retainer 1364 between tubular section end portion 1326 and endeffector tip portion 1312, such that the first and second projections1376 and 1378 of the upper section 1368 are inserted into the first andsecond recesses 1380 and 1382 of the lower section 1370 of the sutureretainer 1364. The controller bias member 1330 provides a substantiallyconstant compressive force to the suture retainer 1364.

[0582] Energy is applied to the suture retainer 1364 through the endeffector 1310 to effectively heat the end portions of the first andsecond projections 1376 and 1378 of the upper section 1368 into atransition temperature range for the polymeric material of theprojections 1376 and 1378. The compressive force applied to the sutureretainer 1364 by the controller bias members 1330 causes the heatsoftened material of the projections 1376 and 1378 to flow in therecesses 1380 and 1382. To a lesser extent, material of the uppersection 1368 is heated and also flows in the recesses 1380 and 1382.

[0583] As this occurs, the heated material of the projections 1376 and1378 may be forced upward toward the suture. The heated material tendsto bond to the suture. If the suture retainer 1364 is constructed sothat the center projection 1384 is deformed to the same extent as theprojections 1376 and 1378, heat softened material of the centerprojection 1384 would flow into the passages 1372 and 1374.

[0584] As the heated material of the projections 1376 and 1378 is causedto flow in the recesses 1380 and 1382, the size of the passages 1372 and1374 is decreased. This results in the suture being firmly clampedbetween the upper and lower sections 1368 and 1370 of the sutureretainer 1364. The force applied to the suture by the upper and lowersections 1368 and 1370 of the suture retainer 1364 is effective todeform the suture from the circular cross sectional configuration into agenerally oval cross sectional configuration.

[0585] There is some bonding of material of the suture retainer 1364 tothe suture to further interconnect suture and the suture retainer 1364.However, the amount of force and energy transmitted from end effector1312 to the suture retainer 1364 is sufficient to effect a plasticdeformation of the material of the suture retainer 1364 withoutexcessive plastic deformation of the material of the suture. By avoidingexcessive deformation of the material of the suture, weakening of thesuture is avoided. Thus, once the plastic deformation of the sutureretainer 1364 has been effected by the transmission of force and energyto the suture retainer 1364, the upper and lower sections 1368 and 1370of the suture retainer 1364 are fixedly interconnected with the suturewithout significantly weakening of the suture.

[0586] The energy which is applied to the suture retainer 1364 by theenergy application apparatus 640 may be thermal energy, vibratoryenergy, or light energy. The energy may be transmitted by radiofrequency waves, ultrasonic waves, heat waves, or light waves. Theenergy may be vibratory ultrasonic, light, heat, or radio frequencyenergy.

[0587] In method of use, the controller assembly 1302 is secured to thehandle assembly 1300 as described above. The suture retainer 1364 isloaded into the tubular section 1322, between the tubular section endportion 1326 and the end effector tip portion 1312. The suture retainer1364 is loaded into the tubular section 1322 by actuating the tensionlever 1328, transmitting a force to the bias member 1330. The forcetransmitted through the bias member 1300 moves the tubular section 1322,forming a gap between the tubular section end portion 1326 and the endeffector tip portion 1312. The suture retainer 1364 is positioned in thegap, with the lower section 1370 of the suture retainer 1364 engagingthe end portion of the tubular section 1326.

[0588] Once the suture retainer 1364 has been positioned in the gapbetween the tubular section end portion 1326 and the end effector tipportion 1312, the tension lever 1328 is released. When the tension lever1328 is released, the bias member 1330 is effected to urge the tubularsection end portion 1326 towards the end effector tip portion 1312,closing the gap. This results in the suture retainer 1364 being clampedbetween the tubular section end portion 1326 and the end effector tipportion 1312. The tip protrusion 1314 on the end effector tip portion1312 is pressed into the recess 1386 in a upper section 1368 of thesuture retainer 1364, capturing the upper section 1368 of the sutureretainer 1364. The bias member 1330 is effective to apply a constantpredetermined biasing force to the suture retainer 1364.

[0589] During performance of a surgical procedure, the suture may bemoved through a cannula to a location disposed within a patient's body.The suture is then positioned relative to the tissue at the remotelocation in the patient's body. However, it should be understood thatthe cannula may be omitted and the suture moved through an openincision.

[0590] If the applicator assembly 640 is utilized to move the sutureretainer 1364 through a cannula into the patient's body before thesuture is positioned the suture retainer 1364, suitable instruments maybe utilized to grip the suture in the patient's body and to move thesuture through the suture retainer 1364. The instruments which engagethe suture and move it through the suture retainer 1364 while the sutureretainer 1364 is gripped by the applicator assembly 640 may extendthrough the cannula along with the applicator assembly 640.Alternatively, the instruments which move the suture through the sutureretainer 1364 may be moved into the patient's body through a cannulaspaced from the cannula through which the applicator assembly 640 movesthe suture retainer 1364 into the patient's body. In order to minimizeincisions in the patient's body, it may be preferred to utilize a singlecannula to accommodate movement of the applicator assembly 640, sutureretainer 1364, suture positioning instruments, and the suture into thepatient's body.

[0591] While the suture retainer 1364 is gripped with a predeterminedconstant force by the applicator assembly 640, the suture retainer 1364is moved to a desired position relative to the body tissue. To positionthe suture retainer 1364 relative to the body tissue, the surgeon holdsthe handle 1304 of the applicator assembly 640 in one hand and tensionsthe suture with the other hand. The surgeon then manually applies forceagainst the handle 1304 to slide the suture retainer 1364 along thetensioned suture toward the body tissue. The relatively long tubularsection 1322 and end effector 1310 enable the applicator assembly 640 tomove the suture retainer 1364 through a small incision to a remotelocation in a patient's body as the suture retainer 1364 slides alongthe suture.

[0592] Once the suture retainer 1364 has been positioned in a desiredrelationship with body tissue and the suture, the suture is pulled witha predetermined force. This results in a predetermined tension beingestablished in the suture. While the predetermined tension is maintainedin the suture, the suture retainer 1364 is connected to suture, holdingthe suture against movement relative to the suture retainer 1364. Toeffect plastic deformation of the suture retainer 1364 and connection ofthe suture retainer 1364 with the suture, energy is transmitted from anenergy source through the end effector 1310 to the suture retainer 1364.At this time, the suture retainer 1364 is clamped between the tubularsection end portion 1326 and the end effector tip portion 1312.

[0593] As noted above, the surgeon pulls on the suture with apredetermined force, holding the suture in tension and maintaining thepredetermined force on the suture during the connection of the sutureretainer 1364 to the suture. Alternatively, the suture may be tensionedusing the suture tensioners 1350 on the controller assembly 1302. Oncethe suture retainer 1364 has been positioned in a desired relationshipwith body tissue and the suture, the suture is pulled with apredetermined force. This results in a predetermined tension beingestablished in the suture. The suture in wrapped about the pulleyportion 1354 of the suture tension projection 1352, and cinched to thecleat 1356. The suture tensioner 1350 maintains the tension on thesuture. While the predetermined tension is maintained in the suture, thesuture retainer 1364 is connected to suture, holding the suture againstmovement relative to the suture retainer 1364. To effect plasticdeformation of the suture retainer 1364 and connection of the sutureretainer 1364 with the suture, energy is transmitted from an energysource through the end effector 1310 to the suture retainer 1364. Theuse of the suture tensioner 1350 to hold the suture, frees up thesurgeon from holding the suture, maintaining the predetermined force onthe suture during the connection of the suture retainer 1364 to thesuture.

[0594] In the illustrated embodiment of the applicator assembly 640, theenergy source is a source of ultrasonic vibratory energy at a frequencyabove that which can normally be detected by the human ear, that isabout 16 to 20 kilohertz. Although there are a wide range of frequencieswhich may be utilized, it is believed that it may be desirable to useultrasonic energy having a frequency of between 20 kilohertz and 70kilohertz. It is believed that it may be desired to use ultrasonicvibratory energy of a frequency between 39.5 and 41 kilohertz. When anactuated switch is closed, ultrasonic vibratory energy is transmittedthrough the end effector 1310 to the suture retainer 1364. Theultrasonic vibratory energy creates frictional heat which is effectiveto heat material of the suture retainer 1364 into its transitiontemperature range while the material of the suture remains at atemperature below its transition temperature range. The actuated switchcan be external to the applicator assembly 640, for example, a footpeddle, or incorporated into the applicator assembly 640, for example atrigger on the handle.

[0595] Referring again to FIG. 25, a generator 666 is connected with astandard electrical power supply (120-240 volts). The generator 666converts the standard electrical power supply from 50/60 hertz to anultrasonic frequency, that is a frequency greater than 20 kilohertz. Thehigh frequency electrical energy is conducted through a cable 638 to themember 640.

[0596] The generator 666 includes a transducer which transformselectrical energy from the power supply into mechanical vibration. Thisis accomplished by using electrostrictive elements called piezoelectriccrystals. The piezoelectric crystals give off electricity when acompressing or expanding pressure is exerted on them. The opposite isalso true: when an electric current is applied, the crystals expand orcontract and exert a force. The piezoelectric crystals expand andcontract as an alternating electrical (AC) current is applied to them.This mechanical energy is then passed to the booster. It is contemplatedthat the power supply can be an external power supply connected to thegenerator 666, such as a wall socket.

[0597] Alternatively, the applicator assembly 640 can include aninternal power supply, cordless, wherein the power supply is disposed inthe handle 642 of the applicator assembly 640. Similarly, the generator666 is disposed in the handle 642, wherein the generator includes, forexample, piezoelectric crystals operably connected to the internal powersupply. The internal power supply can be a battery or a rechargeablebattery with an external recharging unit, which provides a directelectrical (DC) current. A converter is interposed between the batteryand the piezoelectric crystals, converting the DC to AC current forsupply to the piezoelectric crystals.

[0598] Although described as using ultrasonic energy, it is understoodthat in other embodiments, different types of energy or combination ofenergies can be utilized to plastically deform the suture retainer 1364.These types of energy or combination of energies can include, but not belimited to, ultrasonic energy, radio frequency (RF) energy, laserenergy, infrared energy, microwave energy, ultrasound energy, andcontact heating energy. For example the applicator assembly 640 of thepresent invention can include a bimodal energy source, whereinultrasonic and/or RF energy can be provided to plastically deform thesuture retainer 1364. This is particularly useful since one energy typetends to heat from the inside of an object and spreads outwardly, whilethe other type tends to heat from the outside of an object and spreadsinwardly.

[0599] It will be appreciated by persons skilled in the art that thepresent invention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention, which is limited only by the following claims.

What is claimed:
 1. An surgical device for attaching a retainer to asuture for securing tissue in a patient's body, comprising: a firstmember including a first compression element; a second member includinga second compression element, the second member being in movablerelation with the first member from a first position to a secondposition, wherein the first compression element and the secondcompression element are configured to receive the retainer therebetween; a suture tensioner positioned on the second member andconfigured to receive the suture, maintaining a substantially constanttension on the suture during attachment of the retainer thereto; and anenergy source operably connected to the first compression element fortransmitting an energy to the retainer for attachment to the suture. 2.The surgical device according to claim 1, the second member comprising atubular section including a proximal end and a distal end, the distalend having a gapped portion with the second compression element beingintegrated into the gapped portion.
 3. The surgical device according toclaim 2, wherein the first member is positioned through the tubularsection, such that the first compression element is in opposing relationto the second compression element.
 4. The surgical device according toclaim 3, wherein the second compression element is configured to receivea first portion of the retainer, preventing movement of the firstportion of the retainer in the surgical device.
 5. The surgical deviceaccording to claim 4, wherein the first compressive element isconfigured to capture a second portion of the retainer, such that thesecond portion of the retainer is separated from the first portion ofthe retainer when the second member is moved from the first position tothe second position.
 6. The surgical device according to claim 2, thesecond member further comprising an actuation member operably connectedto the proximal end of the tubular section, wherein the actuation memberoperates to move the tubular section from the first position to thesecond position.
 7. The surgical device according to claim 6, whereinthe actuation member includes a bias member biasing the tubular sectioninto the first position.
 8. The surgical device according to claim 7,wherein the bias member imparts a compressive force of between about 1lb. and 20 lbs. on the retainer interposed between the first and secondcompression elements.
 9. The surgical device according to claim 1,wherein the suture tensioner comprises a bias member.
 10. The surgicaldevice according to claim 9, wherein the bias member imparts a tensionof between about 2 lbs. to 10 lbs. on the suture.
 11. The surgicaldevice according to claim 1, wherein the second member is removableattachable to the first member.
 12. The surgical device according toclaim 1, wherein the energy source is an external energy source.
 13. Thesurgical device according to claim 1, wherein the energy source is aninternal energy source disposed within a handle portion of the firstmember.
 14. The surgical device according to claim 13, wherein theinternal energy source is a rechargeable battery.
 15. The surgicaldevice according to claim 1, herein the energy provided by the energysource is selected from the group consisting of radio frequency (RF)energy, laser energy, microwave energy, ultrasound energy, contactheating energy, and combinations thereof.
 16. The surgical deviceaccording to claim 15, wherein the first member is configured totransmit at least two different types of energy from the energy sourceto the first compressive element.
 17. An surgical device for attaching aretainer to a suture for securing tissue in a patient's body,comprising: a handle assembly; a controller assembly operativelyconnected to the handle assembly and configured to receive a sutureretainer therein, wherein a portion of the controller assembly ismovable from a first position to a second position relative to a portionof the handle assembly; a suture tensioner positioned on the controlassembly and configured to receive the suture, maintaining asubstantially constant tension on the suture during attachment of theretainer thereto; and an energy source operably connected to the handleassembly for transmitting an energy to the retainer for attachment tothe suture.
 18. The surgical device according to claim 17, wherein thehandle assembly including a handle portion and an end effector operablyconnected thereto, the end effector having a tip portion fortransmitting the energy to the retainer.
 19. The surgical deviceaccording to claim 18, wherein the controller assembly including acontroller and a tubular section having an end portion configured forreceiving the retainer therein, wherein the retainer is positionedbetween the tip portion of the end effector and the end portion of thetubular section.
 20. The surgical device according to claim 19, whereinthe handle assembly is slidably positionable through the controllerassembly positioning the end effector through the tubular section,wherein the tubular section is in movable relation with the end effectorfrom the first position to the second position.
 21. The surgical deviceaccording to claim 20, wherein the tip portion of the end effectorcomprises a protrusion configured for capturing a first portion of theretainer.
 22. The surgical device according to claim 21, wherein the endportion of the tubular section is configured to capture a second sectionof the retainer, such that the second section of the retainer isseparated from the first section of the retainer when the tubularsection is moved from the first position to the second position.
 23. Thesurgical device according to claim 19, wherein the controller comprisesa latch assembly for removable attaching the controller to the handle.24. The surgical device according to claim 23, wherein the controllercomprises a tension lever, including a bias member, in operativeengagement with the tubular section, wherein actuation of the tensionlever moves the tubular section from the first position to the secondposition.
 25. The surgical device according to claim 24, wherein thebias member biases the tubular section into the first position.
 26. Thesurgical device according to claim 25, wherein the bias member imparts acompressive force of between about 1 lb. and 20 lbs. on the retainer.27. The surgical device of claim 19, wherein the suture tensioner ispositioned on the tubular section.
 28. The surgical device according toclaim 27, wherein the suture tensioner comprising a bias member.
 29. Thesurgical device according to claim 28, wherein the bias member imparts atension of between about 2 lbs. to 10 lbs. on the suture.
 30. Thesurgical device according to claim 17, wherein the energy source is anexternal energy source.
 31. The surgical device according to claim 17,wherein the energy source is an internal energy source disposed within ahandle portion of the first member.
 32. The surgical device according toclaim 31, wherein the internal energy source is a rechargeable battery.33. The surgical device according to claim 17, wherein the energyprovided by the energy source is selected from the group consisting ofradio frequency (RF) energy, laser energy, microwave energy, ultrasoundenergy, contact heating energy, and combinations thereof.
 34. Thesurgical device according to claim 33, wherein the first member isconfigured to transmit at least two different types of energy from theenergy source to the first compressive element.
 35. An surgical devicefor attaching a retainer to a suture for securing tissue in a patient'sbody, comprising: a controller assembly including a controller and atubular section having an end portion configured for receiving theretainer; a handle assembly including a handle portion and an endeffector operably connected thereto, the end effector having a tipportion and being slidably positionable through the tubular section,such that the retainer is positionable between the tip portion of theend effector and the end portion of the tubular section with acompressive force being applied to the retainer; a suture tensionerpositioned on the tubular section and configured to receive the suture,maintaining a substantially constant tension on the suture duringattachment of the retainer thereto; and an energy source operablyconnected to the handle assembly for transmitting an energy to theretainer for attachment to the suture.